GENERAL GUIDELINES FOR FOX CASE INVESTIGATOR INITIATED ... · Web viewIt is the responsibility of...

GENERAL GUIDELINES FOR FOX CASE INVESTIGATOR INITIATED PROTOCOLS

It is the responsibility of the Fox Chase Cancer Center Clinical Research Nurse/Coordinator

(CRN/CRC) to verify that the correct version of the protocol is being utilized by the participating

site as indicated by the protocol date supplied by the site on the CRF “On-Study Form”.

A patient at a participating site is not permitted to begin protocol treatment until the Protocol Office

(CRN/CRC) has reviewed the accuracy of the “On-Study Form” and “Eligibility Checklist”

submitted by the site to Fox Chase. A “Registration / Randomization Confirmation Form” will be

faxed to the site with a unique patient sequence number at which point the patient will be officially

registered on the study.

GENERAL GUIDELINES FOR COMPLETING CRF s

Use black ink or black ballpoint pens.

No whiteout, write-overs or erasures are permitted on the case report forms. Draw a single line

through the error to be changed, write the correction nearby, and initial and date the correction.

ALL DATA MUST BE VERIFIABLE ON A SOURCE DOCUMENT.

All protocol-required data fields should be completed (refer to the “Parameters” or “Procedures”

section of the protocol).

A complete cycle is defined in the “schema “ section of the protocol.

All dates should be recorded in mm/dd/yy format.

When additional pages of the same CRF are required, number them sequentially at the top of the form (e.g. of 2).

At the top of each CRF page, patient specific information should be recorded in the heading.

This must correspond to the information entered on the On-Study Registration page.

The ‘original” CRF copies will be submitted to Fox Chase Cancer Center. Each site will

maintain a photocopy of the CRFs.

The CRF Protocol Flow Sheets will require you to indicate the cycle, day, week, month or

follow-up visit number, these can be abbreviated with a capital C, D, M, or FU# respectively.

If a unique CRF is required to monitor a patient on a specific protocol, they will be provided in

the CRF packet included with the protocol. The protocol CRN/CRC listed on the protocol title

page is responsible to provide the instructions for the completion of this form(s).

The protocol parameters must be followed for each specific protocol.

ON-STUDY FORMAll information on this page must be completed.

PATIENT DEMOGRAPHICS Provide a patient identification number, which may be a medical record number, social security

number, or any unique identifier used at your institution. Middle Initial - If no middle initial is given, use a dash (-) Race - Specify Black, White, Hispanic, Asian/Pacific Islander, American Indian, etc.PROTOCOL INFORMATION Group: Identify the group sponsoring the study. Protocol Number: Identify the number used by the sponsoring group. Date Registered: Date the patient was assigned a unique patient sequence number. Start of Treatment or Observation: Start of treatment is the date of first protocol drug

administration. Start of observation occurs when the protocol does not involve therapy and is therefore the date registered.

Date of Diagnosis: The date of original diagnosis this particular protocol targets. (In some cases, a patient may have a second primary). This date must be documented with a positive pathology report.

Sequence #: Assigned by the sponsor for that patient. Arm: If applicable, enter the arm to which the patient was assigned. If direct assignment to a

single arm study, arm will equal "A". Baseline PS (performance status): Utilizing the ECOG scale (also referred to as a Zubrod scale)

indicate the patient’s performance status at baseline. Treating MD: Name of the physician treating the patient while on study. This should correspond

to the physician that signed the patient's consent form (a Fellow or Resident is not acceptable). Treatment Hospital: Provide the name of the site where the patient will be treated. New to FCCC (Specific to FCCC patients only):

"old" = patient has received any type of prior therapy for this cancer at FCCC "new" = this is the first cancer therapy for this patient at FCCC.

DISEASE PATHOLOGY Grade: Specify the histologic grade at the time of original diagnosis. (Well differentiated = Low

grade, Moderately differentiated = Intermediate grade, Poorly differentiated = High grade). Please note: If the patient's histology contains more than one grade. e.g. moderate to poorly differentiated, record the worst grade.

Site: Enter the site of the cancer. Refer to the pathology report for this information (be specific e.g. sigmoid colon vs. colon).

TNM Stage at Diagnosis: Enter the TNM stage at the time of original diagnosis for solid tumor patients. If the staging standard for the disease being treated is other than a TNM format, enter the AJCC stage at original diagnosis.

Histology: Enter the specific histology for which treatment is being administered (adenocarcinoma, squamous…etc.).

PROTOCOL MANAGEMENT INFORMATION Most Current Amendment Approved by the IRB: Record the most recent amendment # and date

it was approved by the IRB. Person Completing the CRF's for this patient: The person(s) to whom queries should be

addressed.

Entered into PTS by: And Faxed Information: Check the appropriate box and enter date faxed.

ON-STUDY FORM

DEMOGRAPHIC INFORMATION

PATIENT ID#: 123456 NAME: DOE JANE A LAST FIRST MI

DATE OF BIRTH: 08 / 04 / 45 RACE: WHITE SEX: FEMALE

PROTOCOL INFORMATION

GROUP (CIRCLE ONE): DRUG CO., ECOG, GOG, FOX CHASE CANCER CTR., NSABP, PHASE I,

SWOG, RTOG, ACOSOG, CTEP

PROTOCOL #: IRB 97-021 DATE CONSENT SIGNED: 10 / 04 / 99

DATE REGISTERED: 10 / 08 / 99 START OF TREATMENT OR OBSERVATION: 10 / 08 / 99

DATE OF DIAGNOSIS: 06 / 12 / 91 SEQUENCE #: 015 ARM: A BASELINE PS: 1

TREATING MD: SAM SMITH MD TREATMENT HOSPITAL: FOX CHASE

FOX CHASE STAFF USE ONLY: NEW TO FCCC: OLD NEW (CIRCLE ONE)

DISEASE DATA

GRADE: MODERATELY DIFF. T 3 N 2 M 0 STAGE AT DIAGNOSIS

AJCC SUMMARY STAGE: N/A

SITE: LARYNX HISTOLOGY: SQUAMOUS CELL

MOST CURRENT AMENDMENT APPROVED BY THE IRB: #2 08 / 17 / 99

PERSON COMPLETING THE CRF’S FOR THIS PATIENT: MARY HELPFUL NAME

ENTERED INTO PTS BY: MARY HELPFUL ON: 10 / 08 / 99 NAME

COPY FAXED TO NETWORK RESEARCH MANAGER: NOT APPLICABLE YES: DATE / /

03/02 kaps

ON-STUDY - MEDICAL HISTORY

All sites should be answered with either NO or YES. If YES is checked, details should be provided.

Any past medical history should be included on this page, except for current cancer related history. (e.g. if the patient currently has lung cancer yet had a diagnosis of ovarian cancer 10 years ago, then genitourinary disease should be checked yes and ovarian cancer would be recorded with the year this was diagnosed.)

Allergy - Pertains to drug allergies as well as all other allergies. (food, newsprint, etc.).

Smoking History - Should state # of packs per day or cigars per day or pipes per day multiplied by the number of years the patient smoked; the year the patient stopped smoking; or if the patient is currently smoking, write "current".

"Other" - Use to specify anything that is not covered under another site (this is a catchall category for miscellaneous diagnoses).

ON-STUDY - MEDICAL HISTORY

PT. INITIALS: JAD PT. ID#: 123456 PROTOCOL# : IRB 97-021 SEQ.#: 015 PAGE#: 1

PLEASE PROVIDE A RESPONSE FOR EACH AREA LISTED NO YES IF YES IS CHECKED, PROVIDE DETAILS

CARDIOVASCULAR DISEASE:

BR0NCHOPULMONARY DISEASE:

COPD Dx 1990

HEPATOBILIARY DISEASE:

GASTROINTESTINAL DISEASE:

Diverticulitis Dx 1984

GENITOURINARY DISEASE:

Tubal ligation 1985D&C 1976

ENDOCRINE/METABOLIC DISORDERS:

Hypothyroid Dx 1977

HEMATOLOGICAL DISEASE:

Chronic mild anemia

DERMATOLOGICAL DISEASE:

Trach tube placed 1991

MUSCULOSKELETAL DISEASE:

Osteoarthritis lumbar spine Dx 1970s

NEUROLOGICAL DISEASE:

PSYCHOLOGICAL DISEASE:

IMMUNOLOGICAL DISEASE:

ALLERGY:

Bactrim – sulfa drugsSeasonal

EENT DISEASE:

Tonsillectomy as a child

ETOH USE:

SMOKING HISTORY: (# of cigarette packs per day & # years smoked or # cigars or pipes smoked per day & # years smoked and # date stopped if applicable

1ppd cigs x25 years quit 1991

OTHER: (specify)

03/00 emk

ON-STUDY - PAST CANCER TREATMENT HISTORY

Document any past treatment for this cancer that the patient may have had.

List past treatment histories in chronological order beginning with the date of diagnosis.

Surgery: Specify any cancer related surgery the patient had and the date of the procedure. If there was residual disease after this procedure, check the applicable yes or no column.

Radiation: Specify Site, Total Dose and Dates. If detailed treatment records are not available, at a minimum, provide the month and year that treatment was given.

Chemo, Hormone, or Immunotherapy: List the drug(s) given and the dates of the first and last dose received. If detailed treatment records are not available, at a minimum, provide the month and year that treatment was given. When writing the drug name(s), it is acceptable to place commonly utilized regimens on a single line (CMF, 5FU/Leucovorin, etc.). A response to the prior treatment will be recorded using the key codes found at the bottom of the form. Please refer to page 14 for an explanation for CRu (unconfirmed complete response).

**If the patient received adjuvant treatment then “ADJ” should be indicated in the response column.

ON-STUDY - PAST CANCER TREATMENT HISTORY


CANCER RELATED SURGERY (including diagnostic procedures): (If none, circle none) NONE RESIDUAL DISEASE

Post Surgery

PROCEDURE/SITE DATE YES/NO

_BX LARYNX__________________________________________________ _06_/_12_/_91_ ____/_____

_TOTAL LARYNGECTOMY, RADICAL NECK DISSECTION_____________ _06_/__26/_91_ _____/____

_BX RLL LUNG MASS___________________________________________ __07/__18/_94_ ____/_____

_BX LLL LUNG MASS___________________________________________ _06_/_12 /_95_ __ _ _/_____

_____________________________________________________________ ____/____/____ _____/_____

_____________________________________________________________ ____/____/____ _____/_____

_____________________________________________________________ ____/____/____ _____/_____

RADIATION THERAPY: (If none, circle none) NONE

SITE TOTAL DOSE FIRST DOSE LAST DOSE

__upper neck & larynx_______________ __6000 cGy _08_/_12_/_91_ _10_/__-_/_91_

_RLL & hilar mass__________________ _6500 cGy__ _07_/_25_/_94_ _09_/_02_/_94_

_________________________________ ___________ ____/____/____ ____/____/____

CHEMO, HORMONE, OR IMMUNOTHERAPY: (If none, circle none) NONE

TYPE RESPONSE* FIRST DOSE LAST DOSE

_Liposomal platinol___________________________ _PR_______ _08_/_10_/_98 _10_/_09_/_98_

___________________________________________ __________ ____/____/____ ____/____/____

___________________________________________ __________ ____/____/____ ____/____/____

___________________________________________ __________ ____/____/____ ____/____/____

___________________________________________ __________ ____/____/____ ____/____/____

___________________________________________ __________ ____/____/____ ____/____/____

___________________________________________ __________ ____/____/____ ____/____/____

___________________________________________ __________ ____/____/____ ____/____/____

*RESPONSE CODE: COMPLETE RESPONSE=CR; UNCONFIRMED COMPLETE RESPONSE=CRu; PARTIAL RESPONSE=PR; STABLE=SD; PROGRESSION=PROG; NOT EVALUABLE=NE; NOT APPLICABLE=NA

(PLEASE TRY TO DOCUMENT A RESPONSE BUT, IF UNOBTAINABLE, PLACE A DASH ( - ) IN THE CORRECT SPACE.) IF THE PATIENT RECEIVED ADJUVANT TREATMENT, “ADJ” SHOULD BE INDICATED IN THE RESPONSE COLUMN.

PROTOCOL FLOW SHEET – TREATMENTThis form is an ongoing-cumulative summary of each cycle.

Date: Record the date of labs, treatments, physician visits (scheduled as well as additional or unscheduled visits) across the top row of the table.

Cycle: Enter the word “BASELINE” or the cycle # and the protocol parameters for timing of events. Examples include: C1Day8, C1W6, or Other indicators such as 12month FU

(follow-up). PS/WT: Enter the documented performance status and weight (lbs. or kg) for each evaluation time-

point per protocol parameters and whenever significant changes occur. BP/Temp: Enter the documented BP and temp for each evaluation time-point per protocol

parameters and whenever significant changes occur. "Afeb” can be used when appropriate. Treatment: Record each study drug, dose level and route of administration on a separate line in

the far-left column of the table. Enter the exact dose administered to the patient in the same horizontal row under the appropriate date column.

Modifications: If a scheduled dose(s) is/are not given, write "HOLD" in the appropriate date column in the Treatment row under the “Modification:” option. If a dose modification is made, indicate the % of the total dose administered. In the COMMENT column to the far right of the table, note the date and reason that treatment was either modified or not given.

If growth factors are given circle the appropriate agent and write the dose administered under the appropriate date. You may indicate dosing to cover a period of time such as 300mcg/dx7.

On combined modality protocols, record the daily XRT dose in the appropriate date column. Also record the cumulative XRT dose in the appropriate column. If XRT is delayed, held, or not given for any reason, an explanation will be required in the COMMENT column.

Enter the # of units of PRBC's (packed red blood cells) and/or PLTS (platelets in units) transfused when applicable under a date when the transfusion occurred.

Lab Code: This gray row is used to indicate which lab is used to acquire results. Please see Lab Code-Source ID in the upper 1/3 of the far right column of the page. Each lab used to obtain results for the patient will be identified and assigned a code (A, B, C, D, etc). Remember to obtain for your records an outside lab CLIA and lab normals.

List lab values in the appropriately dated vertical column. All labs required by protocol as well as those obtained to more closely monitor the patient are to be recorded for the appropriate cycle. Grade abnormal lab values in red ink, next to the abnormal lab result, according to the CTC v.2.0 guidelines or as outlined in the protocol.

Acceptable CODES to be used on this page are:ND = Not Done (use when a required test was not performed) 0 = Zero is a result and should be used only to indicate a 0 value = Dash is used when there is no result given or procedures not required (e.g. Transfusions)

Enter the patient's height, weight, & BSA used to calculate drug doses for each cycle in the appropriate blanks in the upper Right corner of the table.

In the upper right corner of the form, note the date of any admission whether scheduled or not with the appropriate discharge date. This is to include any outside hospital admissions. Further comments concerning the admission should be recorded in the COMMENT section.

The COMMENT section in the far right column of the table is to be used to record any notes pertaining to the patient's health during the study trial. Notation is to be made documenting the reason for dose reductions, treatment delays, X-ray, EKG, MRI, CT results, additional medications required, etc. These notes can be made by either the CRC or CRA.

PROTOCOL FLOW SHEET - TREATMENT

PROTOCOL FLOW SHEET - TOXICITIES/MEDICAL PROBLEMS

This form is an ongoing-cumulative summary of each cycle.

Record the date of patient assessment at the top of the column. Toxicities/Medical Problems:

Record BASELINE in the first column in the ‘cycle’ box. Enter baseline data in the first column including date, weight, and any previously existing medical problems and symptoms (those present within 7 days from the start of treatment or as specified by the protocol) prior to the start of protocol therapy (causal relationship will be assigned 1-unrelated).

Record at the top of subsequent columns the date, which represents a patient assessment, time-point per protocol parameters. List in the far-left column all toxicities or medical problems observed in the course of the treatment cycle. In the appropriate date column, list the worst grade for toxicity observed for that cycle.

The CTC. V2.0 will be utilized for grading purposes unless otherwise specified in the protocol.

Upon entering a toxicity grade, you will refer to the ‘CAUSALITY’ code box to assign a cause value for each graded event.

You will note the cycle # and day/week corresponding to the observation or finding. There must be a minimum of one column recorded per cycle. If a patient reports no

problems or toxicities in the cycle make a notation to this effect in the comment section to the far right of the table and draw a diagonal line through the column.

Abnormal lab values will be listed on this CRF. If the patient is suffering from a concomitant illness such as flu, it is not necessary to document

each symptom (e.g. achiness, headache, and fever). This can be documented simply as “flu”. At the bottom of each column, indicate if the patient will be continuing on study.

PROTOCOL FLOW SHEET – CONCOMITANT MEDICATION

Brand or generic drug names may be used. Give the dose, units and route of administration for the agent as applies to the schedule provided in

the schedule box. In the case of combination drugs (e.g. Bactrim), provide the total number of tablets/capsules taken on the schedule provided in the schedule box.

The following abbreviations for the drug schedule box may include but are not limited to the following:

P.R.N. = as neededqd = dailyqod = every other daybid = twice dailytid = three times dailyqid = four times a daybiw = twice a weektiw = three times a weekac = before mealspc = after mealshs = bedtimeq X hr = every X hours

Indication refers to the reason the drug is being given. If the patient was on the medication prior to the start of protocol, use “CON” (continuing) in the

Start Date if actual date is unknown. Attempt to record at least a month and year whenever possible.

When a medication is stopped please while the patient is on study, provide the date in the Stop Date box.

The On-going column is used upon completion of the patient’s study participation. If the patient is continuing a drug, a will need to be placed in the appropriate box.

Submit a copy of the concomitant medication form along with each cycle summary data.

PROTOCOL FLOW SHEET - CONCOMITANT MEDICATION

PT. INITIALS: JAD PT. ID#: 123456 PROTOCOL# : IRB 97-021 SEQ.#: 015 PAGE#: 1 of x Prescription Meds

DRUGDAILY DOSE/

UNITS Schedule Indication Start Date Stop Date

On-going

Synthroid 0.1 mg PO qd Hypothyroid CON Procrit 40,000u SC q week Anemia 9/6/98 12/2/99Compazine 10mg PO q 4-6hr PRN Nausea 11/1/99 Granisetron 10mcg/kg IV Pre-chemo Prophylactic n/v 10/8/99 1/7/00Dexamethasone 10mg IV Pre-chemo Prophylactic n/v 10/8/99 1/7/00Lorazepam 1mg IV Pre-chemo Prophylactic n/v 10/8/99 1/7/00Atrovent 2 puffs bid dyspnea 11/1/99

Over-the-Counter / Vitamins

DRUGDAILY DOSE/

UNITS Schedule Indication Start Date Stop Date

On-going

Tylenol Sinus 1 tab PO q 12hr PRN Seasonal allergies

CON

_________________________________ ___________ _________________________________ ___________ _________________________________ ___________

Signature Initials Signature Initials Signature Initials 03/00 emk

TUMOR IDENTIFICATION AND MEASUREMENT FORM

This form is not to be utilized as a source document. Please indicate in the appropriate check box at the top of the page if disease will be assessed utilizing

WHO criteria or RECIST. This will be specified in the protocol. Record the date of baseline films in column 3 and the method of measurement in column 2. Record from your source document, the location of each lesion in the 1st column. In the corresponding

horizontal row, note the image #. In the space provided below the image #, record either the bi-dimensional measurements (WHO) or the single measurement value representative of the longest diameter of the target lesion (RECIST) under the baseline date.

In the event you are utilizing WHO Criteria:Calculate the product of each measured lesion (multiply the two measurements obtained for the individual lesion) and insert the product following the “=” sign. Add the products for each lesion measured at a specific time point and enter this sum in the appropriate column at the bottom. If you are following a single lesion, the product of the one measurement will be recorded.Using the response criteria portion of the protocol, determine the response targets for your patient representing the % that qualifies a PR and the % that qualifies PD. Place these two indicators in the column to the left of the baseline measurements. An example of this is provided on the sample form. Refer to sample on page 15.

If a 50% in the sum of the products = a PR (e.g. 50% = Measurement Total X 0.50)

If a 25% in the sum of the products = PD (e.g. 25% = Measurement Total X 1.25)

In the event you are utilizing RECIST Criteria:Sum the values for all the longest diameter measurement(s) of the measured target lesion(s) and enter that value in the appropriate column at the bottom. Refer to sample on page 17.

If a 30% in the sum of the longest diameters = a PR (e.g. 30% = Sum Total X 0.30 then subtract this value from the Sum Total)

If a 20% in the sum of the longest diameters = PD (e.g. 20% = Measurement Total X 1.20)

As each new set of measurements are obtained, the recording process is repeated. Note the date of the film imaging, the image #, and the measurement(s) of each lesion. Find the products then sum or obtain the single value and sum and indicate the response in the provided box for the column. If the amount of change in measurements does not meet the determinations for a PR or PD, the patient is considered SD (stable disease) unless otherwise specified by the protocol. In some protocols, a MR (marginal response) may be applicable. Follow the guidelines in the specific protocol. Indicate the RESPONSE in the appropriate box below the date of the exam. CRu is oftentimes noted in the context of assessing responses in hematologic malignancies and will be defined in the protocol. An example follows:

“Patients with initial disease sites >8cm in maximum diameter that respond by > 75%…then remains stable and who otherwise meet the criteria cor CR will be classified as CRu”

INSTRUCTIONS FOR THIS CRF CONTINUE ON PAGES 16 AND 17.

PROTOCOL SPECIFIC - FCCC TUMOR IDENTIFICATION AND MEASUREMENTCASE REPORT FORM

MEASUREMENT DETERMINATIONS: Bi-dimensional RECISTUse only one method of evaluation for each lesion during the entire course of the study.

PT. INITIALS: JAD PT. ID#: 123456 PROTOCOL#: 97-021 SEQ.# 015 PAGE#: 1 OFLocation

of Sentinel Lesion (s)

*

Assessment

Method **

EVALUATION DATE9 / 29/ 99

EVALUATION DATE

10 /27 / 99

EVALUATION DATE 11 / 24 / 99

EVALUATION DATE

12 / 22 / 99

EVALUATION DATE

1 / 28 / 00

R posterior pleural base met

CTImage# 10c5.5 X 4.5

Product =24.75

Image# 11 3.5 X 2.4

Product =8.4

Image# 11c2.5 X 2.0

Product =5.0

Image# 11c2.0 X 2.0

Product =4.0

Image# 113.0 X 3.0

Product =9.0

L posterior pleural base met


Product =5.5

Image# 111.8 X 1.8

Product =3.24

Image# 11c1.5 X 1.2

Product = 1.8

Image# 10c1.2 X 1.2

Product =1.44

Image# 113.0 X 2.5

Product = 7.5

L anterior lung met


Product = 9.5

Image# 212.5 X 2.0

Product =5.0

Image# 17c1.8 X 1.3

Product =2.34

Image# 17c1.5 X 1.0

Product =1.5

Image# 202.5 X 2.5

Product =6.25

R upper lobe lung met

CTImage#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image# 192.0 X 2.0

Product =4.0Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product = Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____


Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____


Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____


Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product = Sum of

ProductsOR

Sum of Measured

25% = 49.6950% =19.87

39.75 16.64 9.14 6.94 26.75

Response ***

N/A PR PR PR PD

* Site(s) to be identified by physician prior to patient entry on protocol. Record exact location of lesion(s) within specified organ.** Assessment Methods: CT, CXR, MRI, PE*** Response Codes: CR, CRu, PR, SD, PDNOTE: If a NEW LESION(s) appears, please document LOCATION & Image#. 03/02 kaps

TUMOR IDENTIFICATION AND MEASUREMENT FORM CON’T

Uni-dimensional disease (e.g. splenomegaly, mediastinal and hilar width) will be evaluated using the specific guidelines outlined in the text of the protocol. The value(s) obtained are totaled (if more than one indicator is used) and then multiplied using the same technique described in the sample equation above to define response parameters.

To provide for two potentially different assessment dates for each evaluation time-point, the following guidelines are provided:

Measurements for each disease assessment time point are to be obtained with radiographic studies and a physical exam.

Maintain a baseline column with the date and baseline radiographic measurements (form 1) and the date and baseline PE measurements and/or evaluable disease assessments (form 2). Continue this process in a manner so that each measurable disease assessment time point will be represented with a corresponding column on each page.

A sum of the products will be performed on all product values in the like columns (baseline sum of the products or sum of the values on form 1 will be added to the baseline sum of the products or sum of the values on form 2). It is this total that will be used to determine response.

Evaluable disease will be assessed either by utilizing the “Tumor Identification and Measurement Documentation” form or by utilizing a disease site specific “Response Evaluation Form” provided by the CRN/CRC for the specific protocol.

If the “Tumor Identification and Measurement Documentation” form is to be utilized, request from the CRN/CRC a completed sample document.

If a disease site specific “Response Evaluation Form” is to be utilized, it will be provided with the CRF packet of the protocol along with instructions for use if necessary.

**NOTE: Consistency in the method of measurement and the lesions being followed for response must be strictly maintained. If a CT is required pre-study, then all measurements during the study and at the end of study should follow the same method. Do not change to CXR or PE measurements while the patient is on study. **NOTE: If a unique Response Evaluation Form is necessary for a particular disease process (e.g. Multiple Myeloma, Leukemia, Prostate Cancer), the appropriate form will be provided in the APPENDIX of the protocol with directions for completion.

FOX CHASE STAFF ONLY: If a patient achieves either a PR or CR on therapy, copy the measurement form and either the

CRN/CRC or CRA will sign the copy and place it in the RVC box located in the Protocol Department Manager’s office (see SOP#C012).

PROTOCOL SPECIFIC - FCCC TUMOR IDENTIFICATION AND MEASUREMENTCASE REPORT FORM

MEASUREMENT DETERMINATIONS: Bi-dimensional RECISTUse only one method of evaluation for each lesion during the entire course of the study.

PT. INITIALS: JAD PT. ID#: 123456 PROTOCOL#: 97-021 SEQ.# 015 PAGE#: 1 OFLocation of

Sentinel Lesion (s) *

Assessment Method

**

EVALUATION DATE

9 / 29/ 99

EVALUATION DATE

10 /27 / 99

EVALUATION DATE

11 / 24 / 99

EVALUATION DATE

12 / 22 / 99

EVALUATION DATE

1 / 28 / 00

R posterior pleural base met

CTImage# 10c5.6

Product=

Image# 11 3.5

Product =

Image# 11c2.5

Product =

Image# 11c2.0

Product =

Image# 113.0

Product =

L posterior pleural base met

CTImage# 10c2.5

Product=

Image# 111.8

Product =

Image# 11c1.5

Product =

Image# 10c1.2

Product =

Image# 113.0

Product =

L anterior lung met

CTImage# 17c3.8

Product=

Image# 212.5

Product =

Image# 17c1.8

Product =

Image# 17c1.5

Product =

Image# 202.5

Product =

R upper lobe lung met

CTImage#_____

Product=

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image# 192.0

Product =Image#_____

Product=

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____


Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____


Product =

Image#_____

Product =

Image#_____

Product=

Image#_____

Product =

Image#_____


Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____


Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product =

Image#_____

Product = Sum of

ProductsOR

Sum of Measured

20% = 14.1630% =8.26

11.8 7.8 5.8 4.7 10.5

Response ***

N/A PR PR PR PD

* Site(s) to be identified by physician prior to patient entry on protocol. Record exact location of lesion(s) within specified organ.** Assessment Methods: CT, CXR, MRI, PE*** Response Codes: CR, CRu, PR, SD, PD NOTE: If a NEW LESION(s) appears, please document LOCATION & Image#. 03/02 kaps

PROTOOCOL - END OF TREATMENT FORM

Record the date on which the patient received their last dose of protocol treatment. Select the reason that the patient is being removed from study treatment. If the patient has terminated

treatment due to toxicity, protocol violation, patient non-compliance or another reason, please include an explanation. If the patient terminated treatment due to disease progression, indicate the site(s) of progression.

If the patient dies while on study answer the questions related to the death. Complete the information on the appropriate SAE (Serious Adverse Event) form detailed in the protocol and submit a copy to the sponsor and your IRB.

The patient’s PHYSICIAN will need to complete Section 2 by assigning an overall Best Response to Treatment.

PROTOCOL END OF TREATMENT FORM

PT. INITIALS:_ JAD PT. ID#: 123456 PROTOCOL# : IRB 97-021 SEQ.#: 015 PAGE#: ___1

DATE OF LAST PROTOCOL TREATMENT: 01 / 28 / 00

REASON: (CHECK THE PRIMARY REASON FOR OFF TREATMENT):

ASSIGNED PROTOCOL TREATMENT COMPLETED ( )

PATIENT WITHDRAWAL OR REFUSED FURTHER TREATMENT ( )

TOXICITY ( ) EXPLAIN:_________________________________________

PROGRESSIVE DISEASE () DATE OF PROGRESSION: 02 / 11 / 00

( ) SITES(S) OF PROGRESSION: LUNG ( ) NEW SITE OF DISEASE:____________________________

PROTOCOL VIOLATION ( ) EXPLAIN:_________________________________________

PATIENT NON-COMPLIANCE ( ) EXPLAIN:_________________________________________

OTHER ( ) EXPLAIN:

DEATH (+) ( ) DATE OF DEATH: / /

WAS AN AUTOPSY PERFORMED (check one)? ( ) NO ( ) YES

CAUSE OF DEATH:

(+) IF PATIENT DIED WHILE ON ACTIVE TREATMENT OR WITHIN 30 DAYS OF TREATMENT DATE IRB NOTIFIED: / /

BEST RESPONSE TO TREATMENT:

NOT EVALUABLE ( ) EXPLAIN:________________________________________

COMPLETE RESPONSE ( )

PARTIAL RESPONSE ( )

STABLE DISEASE ( )

PROGRESSION ( )

ADDITIONAL COMMENTS:________________________________________________________

______________________________________________________________________________________

Sam Smith MDPHYSICIAN SIGNATURE

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FOX CHASE STAFF ONLY:

PROTOCOL - FOLLOW UP FORM

This form is to be completed according to the specifications in the protocol however general guidelines follow:

q 3 months for the 1st 2 years off study q 6 months during years 3-5 off study.

Yearly after 5 years off study.

SECTION ONE will be completed for patients being followed for survival only after coming off treatment for disease progression and overall survival is outlined as a protocol objective.

SECTION ONE and TWO will be completed for those patients removed from study without experiencing disease progression. SECTION TWO will be completed until the patient experiences disease progression or expires.

For FCCC and Network patients: At the time of each follow up, the date of this follow up must be entered into the Patient Tracking System. For Network patients, either the Network site or the FCCC Network Office will enter this data. Fax the Long- Term Follow-Up page to the Network coordinator as well as the Protocol CRN/CRC at Fox Chase.

For Non-Network patients:Each follow up will be entered into the Patient Tracking System by the Protocol CRN/CRC orCRA.

PROTOCOL - FOLLOW-UP FORM


*************************************************************************************** TO BE COMPLETED ACCORDING TO THE SPECIFICATIONS IN THE PROTOCOL*

*******************************************************************************************************

**IF TREATMENT WAS TERMINATED DUE TO PROGRESSIVE DISEASE –PLEASE COMPLETE SECTION ONE ONLY

SECTION ONE

PATIENT STATUS - (CHECK ONE)

( ) ALIVE DATE LAST KNOWN TO BE ALIVE: 06 / 23 / 01 FURTHER FOLLOW UP REQUIRED PER PROTOCOL ( ) YES ( ) NO

( ) DEAD DATE OF DEATH: ____/____/____

CHECK ONE: ( ) DISEASE RELATED ( ) TOXICITY FROM SUBSEQUENT TREATMENT ( ) OTHER (EXPLAIN) _________________________ AUTOPSY? NO_______ YES _________

SECTION TWO

CURRENT DISEASE STATUS (CHECK ONE)

( ) COMPLETE REMISSION CONTINUES

( ) PARTIAL RESPONSE CONTINUES

( ) MARGINAL RESPONSE CONTINUES

( ) STABLE DISEASE CONTINUES

( ) PROGRESSION OBSERVED DATE OF PROGRESSION ____/____/____ SITE(S) OF PROGRESSION ______________________________________ ( ) NEW PRIMARY – SPECIFY:___________________________________

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