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Purpose

Record all sites of disease, even if they will not be followed for response.

Extent of Disease eCRF - Lesions Identification

Field Name

Description / Instructions

Format

Visit Date

The Visit Date is optional on this case report form. Hit the "Tab" key to leave it empty and move to the Lesion # field.

DD-MMM-YYYY

Lesion #(m)

Select a unique number for each lesion. Once a lesion number is designated for a specific lesion, that number may not change or be used to denote a different lesion.

Note: This lesion number must appear at least once on the bottom repeating group.

Use pick list.

Anatomic Site(m)

Select the anatomic position where the lesion is located, i.e. Lung, Skull, etc.

Use pick list.

Description of Location(m)

Select a brief description of the lesion location.

Use pick list.

Description of Lesion

If applicable, enter a brief description of each lesion, e.g. cystic, well-defined, encapsulated, necrotic appearing center.

32 characters

Previously Irradiated(m)

If the site or lesion has previously been irradiated, enter "Y" for Yes, otherwise enter "N" for No.

Use pick list.

Measurable / Non-Measurable(m)

Enter "M", for measurable, and "N" for non-measurable, as defined in the protocol.

Use pick list.

Target / Non-Target(m)

Enter "Target" for target lesions that will be assessed for response (e.g. using the RECIST response criteria). Enter "NonTarget" for non target lesions.

Note: Only applicable for studies that use RECIST criteria. It applies to the first time the lesion is detected. It should not be changed based on the subsequent evaluations. For CTMS studies, ‘Target’ will be submitted as ‘Y’, ‘NonTarget’ will be submitted as ‘N’.

Use pick list.

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

Validations

Code

Description

Resolutions

EXT01

Lesion Number appears more than once on the description section.

Extent of Disease Lesion Number should be unique in the description section (top repeating group).

Extent of Disease eCRF - Lesions Measurements

Field Name

Description / Instructions

Format

Lesion #(m)

Select a lesion number from the pick list.

Note: This lesion number must appear in the description section (top repeating group).

Use pick list.

Course #(d)

Indicates the course number that this lesion evaluation was done in as derived from the course initiation start date.

5 digits

Day in Course(d)

Indicates the day since the beginning of course that this lesion evaluation was done as derived from the course initiation start date.

5 digits

Evaluation Date(m)

Enter the date of the evaluation (i.e.: date of CT scan). Do not enter the date of the report or when the results were received.

DD-MMM-YYYY

How Measured(m)

Select how the lesion measurement was determined. The same method should be used to measure a specific lesion throughout the study. For example, if the measurements were determined by a chest x-ray, enter CXR.

Use pick list.

First Longest Measurement

Enter the longest lesion measurement in centimeters.

Note: for studies that use RECIST criteria, it should always measure the longest diameter of the lesion even if the actual axis is different from the one used to measure the lesion initially.

6 digits and 2 decimals

Second Longest Measurement

Enter the second longest lesion measurement in centimeters.

Note: not applicable for studies that use RECIST criteria.

6 digits and 2 decimals

Third Longest Measurement

Enter the third longest lesion measurement in centimeters.

Note: not applicable for studies that use RECIST criteria.

6 digits and 2 decimals

Product

Enter the tumor product which is the multiplication of the First and Second Longest Measurements.

8 digits and 2 decimals

Total Tumor Volume

Enter the total tumor volume which is the multiplication of all three measurements.

8 digits and 2 decimals

Evaluation #(m)

Number each evaluation sequentially for each lesion. Use 0 for the baseline evaluation, 1 for the first evaluation, 2 for the second evaluation, etc.

Note: this is the number of the set of scans done after the baseline. For example, if a new lesion was found on the third set of scans that occurred at the end of the course 4, the evaluation number should be 3.

2 digits

Evaluation Code

Select the status of non-measurable lesions at the time of each evaluation.
B - Baseline (use for the initial lesion evaluation that was when the treatment started.)
D - Decreasing
I - Increasing
N - New (use for lesions that appear after treatment has started.)
R - Resolved
S - Stable
X - Not Examined
V - Not Evaluable

Use pick list.

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

Validations

EXT02

Lesion Number in the measurement section does not have a corresponding number in the description section (Lesion Identification Page).

Verify that lesion number in the measurement section is recorded in the description section(Lesion Identification Page).

EXT03

Evaluation Number of a "Non-Measurable"lesion is "0" and Evaluation Code is not "B, and vice-versa.

If Evaluation Number of a "Non-Measurable"lesion is "0", Evaluation Code should be "B - Baseline".

EXT12

Lesion is marked as "Measurable" and longest measurement do not exist.

Enter the lesion's longest measurement.

EXT05

Date of Evaluation is in the future.

Enter a date that is equal to or prior to the current date.

EXT09

Lesion is marked as "Non-Measurable" and Evaluation Code was not provided.

Lesion is marked as "Non-Measurable" should have an Evaluation Code.

EXT13

The lesion has an Evaluation Code of "B - Baseline" and the Evaluation Date is not prior to Start Date of the first course.

Correct the lesion's Evaluation Date or the Evaluation Code.

EXT14

Evaluation Date for New lesion is prior to the Start Date of first course.

Enter a date that is equal or after the first course Start Date.

EXT15

Evaluation number for New lesion (with Evaluation Code 'N-New') is 0.

Enter a correct sequential number.

EXT16

New lesion (with Evaluation Code 'N-New') does not have the lowest evaluation number for the corresponding lesion.

Enter a correct sequential number.

Derivations

Code

Field Name

Description

EXT1001

Course #

Course number is derived based on the course initiation start dates and the extent of disease evaluation date.

EXT1002

Day in Course

Number of days since the beginning of the course is derived from the course initiation start date and the extent of disease evaluation date.