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Purpose

Record the course assessment information (tumor imaging data and response data) per protocol at the following time points: when the course is completed, any time the patient is evaluated (i.e. tumor imaging) and when the patient is taken off treatment.

Note: BTTC protocols generally gather tumor imaging data from MRI (unless contraindicated). Response data is based on the RANO Criteria for Response. Some BTTC protocols will also require response to be recorded using the exploratory iRANO criteria. Refer to your specific BTTC protocol for details on the required criteria for capturing response in C3D

Course Assessment eCRF- Course Assessment Summary Tab

Field Descriptions and Instructions

Field Name	Description / Instructions	Format
Visit Date ^(m)	Enter the date the course started.	DD-MMM-YYYY
Is pt NED?	Indicate whether there is no evidence of disease (NED) at assessment. Yes No Unknown	Use pick list.
Max Daily Corticosteroid Dose at assessment	Enter the numeric value for the largest daily corticosteroid dose taken by a patient at the time of an assessment.	8 digits and 2 decimals
Dose UOM	Select the total daily dose units of measurement.	Use pick list.
Steroid dose status	Indicate the status that represents the steroid therapy dose. None Stable Increase Decrease	Use pick list.
Sum of Longest Diameters of all Measurable Lesions (cm)	Enter the numeric value to indicate the sum of the longest diameters of all measurable lesions captured in centimeters (cm).	5 digits and 1 decimals
Sum of TD x PD of all Measurable Lesions (cm2)	Enter the numeric value for total sum of products (transverse diameter multiplied by perpendicular diameter) for all measurable lesions described in square centimeters (cm2).	8 digits and 0 decimals
Overall Response at this assessment	This determination must be adequately documented by the physician in the patient's medical record. The physician will determine the evaluation of overall tumor response by comparing the baseline tumor measurements to those taken after protocol treatment (post-cycle assessment). The overall response is determined based on the RANO Criteria (Wen, Macdonald, Reardon, Cloughesy, Sorensen, Galanis, et al., 2010) as follows: CR - COMPLETE RESPONSE - Requires all of the following: complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions; patients must be off corticosteroids (or on physiologic replacement doses only); and stable or improved clinically. Note: Patients with non-measurable disease only cannot have a complete response; the best response possible is stable disease. PR - PARTIAL RESPONSE - Requires all of the following: ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no progression of non-measurable disease; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at time of baseline scan; and stable or improved clinically. Note: Patients with non-measurable disease only cannot have a partial response; the best response possible is stable disease. SD - STABLE DISEASE - Requires all of the following: does not qualify for complete response, partial response, or progression; stable non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan. In the event that the corticosteroid dose was increased for new symptoms and signs without confirmation of disease progression on neuroimaging, and subsequent follow-up imaging shows that this increase in corticosteroids was required because of disease progression, the last scan considered to show stable disease will be the scan obtained when the corticosteroid dose was equivalent to the baseline dose. PD - PROGRESSIVE DISEASE - Defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR nonenhancing lesion on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy not caused by comorbid events (eg, radiation therapy, demyelination, ischemic injury, infection, seizures, postoperative changes, or other treatment effects); any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor (eg, seizures, medication adverse effects, complications of therapy, cerebrovascular events, infection, and so on) or changes in corticosteroid dose; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. EARLY DEATH - Death prior to completion of protocol criteria UNKNOWN - Progression has not been documented and one or more measurable or evaluable sites have not been assessed Source: Wen PY,Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, et al. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2010;28:1963-72. DOI: 10.1200/JCO.2009.26.3541	Use pick list.
Verifying Physician	Enter the name of the physician who will be responsible for verification. The verifying physician must be educated, trained, and licensed to practice the art and science of medicine; a practitioner of medicine. Do not enter the surgeon as verifying physician.	100 characters
Verified	This term is used primarily by the verifying physician. Upon review of the data entered, the verifying physician will either confirm the disease evaluation data (tumor measurements and response) or indicate to the data manager that the data needs revision. •CONFIRMED •NEEDS REVISION	Use pick list.
Date verified	Enter the calendar date on which the verifying physician verified the patient's disease evaluation assessment data	DD-MMM-YYYY

Validations

Code	Description	Resolutions
TBD

Derivations

Code	Field Name	Description
TBD

Course Assessment eCRF

Field Descriptions and Instructions

Field Name

Description / Instructions

Format

Visit Date ^(m)

Enter the date the course started.

DD-MMM-YYYY

Start Date of Course ^(d)

Shows the Start Date of Course entered in the Course Initiation case report form.

DD-MMM-YYYY

Dose change from TAC entered on Course Initiation CRF ^(m)

Indicate if the patient's treatment was different from that specified by the Treatment Assignment Code (TAC) for this course as entered on the Course Initiation CRF. If the treatment was different, indicate whether this was planned or unplanned, and record the reason, e.g. dose reduction due to toxicity, on the Comments tab of this CRF.

1 - Yes, Planned - change in treatment had been decided before the start of the course, e.g., due to toxicity on a previous course.
2 - Yes, Unplanned - change was not intended at the start of the course, e.g., shortening the course (and thus lowering the dose level) due to adverse events or if there was a drug administration error.
3 - No - patient received the treatment specified in the Course Initiation TAC
9 - Unknown - only when the actual treatment cannot be determined, e.g., when the patient is uncooperative in reporting self-administration of study medication.

Use pick list.

Course Disposition ^(m)

A "completed" course is one that has been conducted in accordance with the protocol with respect to length including the observation period (two day variance allowed). A course is regarded as "discontinued" if it was shorter than specified in the protocol. Select one of the following values:
Comp- Completed
Dis- Discontinued

Use pick list.

Any Adverse Events in this Course? ^(m)

Select "Yes" if any adverse event has occurred during this course. This includes adverse events with onset date belonging to a previous course that resolved during this course or that remain ongoing at the conclusion of this course.
Select "No" if no adverse events occurred during this course.

Note: The event(s) must be recorded on the Adverse Events case report form.

Use pick list.

Reason for Dose modification (Study Agent)

Select the explanation of the cause for a study drug dose modification:

ANTI-CONVULSANT TYPE CHANGE - Anticonvulsant Change
DOSE HELD FOR ADVERSE EVENT - Dose Held for Adverse Event
DOSE HELD PER PROTOCOL GUIDELINES - Dose Held per Protocol Guidelines
DOSE INCREASED PER PROTOCOL GUIDELINES - Dose Increased per Protocol Guidelines
DOSE REDUCED PER PROTOCOL GUIDELINES - Dose Reduced per Protocol Guidelines
DOSING ERROR - Dose Error
N/A - NA (The patient is unable to complete a questionnaire in English, Spanish, or French.)
NO CHANGE - No Change
PATIENT NON-COMPLIAN - Patient Noncompliance
THERAPY DISCONTINUED - Therapy discontinued
UNKNOWN - Unknown

Use pick list.

Has there been any change to the concomitant therapy

Select the term to signify whether there has been a change in a patient's concomitant therapy during the current cycle:

NO
NOT APPLICABLE
TOO EARLY
YES

Use pick list.

RANO Response Date

Enter the date of response based on Response Assessment in Neuro-Oncology Criteria Response (RANO) criteria for Glioblastoma.

DD-MMM-YYYY

RANO Criteria for Response ^(m)

Select the patient's response status based on Glioblastoma Response Assessment in Neuro-Oncology Criteria (RANO). This determination must be adequately documented in the patient's medical record.

AJ - Adjuvant Therapy
CPD - Clinical Progression
CRU - Complete Response Unconfirmed – Complete response assessed but not confirmed as per protocol timeframe.
DU - Disease Unchanged
IMR - Immunoresponse
IPD - Immunoprogression
MR - Minimal/Marginal response
MX - Mixed response
NA - Not Assessed - State the reason in the "Response Note" field.
NE - Not Evaluable - State the reason in the "Response Note" field.
NON-CR/NON-PD - Non-CR/Non-PD
NP - NOT APPLICABLE PER PROTOCOL. Protocol does not require a response assessment during the specific course.
NPB - No Palliative Benefit
NR - NO RESPONSE
PA - Palliative Therapy
PB - Palliative Benefit
PPD - Pseudoprogression
PSR - Pseudoresponse
RD - Responsive Disease
RP - Response
RPD - Radiographic Progressive Disease
SPD - Surgical progression
TE - Too Early to confirm a response.
UK - Unknown

Unless the BTTC protocol includes specific response evaluation criteria, the following guidelines should be observed:

CR - Complete Response - There is a disappearance of all evidence of disease as assessed relative to the baseline at start of treatment, not to previous courses. They must be confirmed by repeat assessments to demonstrate a disappearance of all evidence of disease.
PR - Partial Response - Response is assessed relative to the baseline at start of treatment, not to previous courses. They must be confirmed by repeat assessments. Subsequent evaluations at which tumor sizes are substantially unchanged should be assessed again as the same PR/MR.
PD - Progressive Disease - Response relative to the best disease status (smallest tumor measurement) since treatment began. Thus a tumor re-growth after a PR would be assessed as PD. A PR cannot follow a complete response "CR".
SD - Stable Disease - Tumor growth or shrinkage since the start of treatment is not enough to justify a CR/PR response or a PD progression. Once an actual CR/PR response or PD progression has occurred, an SD assessment is not valid.

Use pick list.

Response Notes

Enter the reason why the Response Assessment is Not Evaluable (NE) or Not Assessed (NA). Some examples could include: protocol not followed, poor quality of scan, patient already treated.

32 characters

iRANO Response Date

Enter the date of response based on iRANO criteria for Glioblastoma.

DD-MMM-YYYY

iRANO Criteria for response

Select the patient's response status based on Glioblastoma Immunotherapy Response Assessment in Neuro-Oncology Criteria (iRANO). This determination must be adequately documented in the patient's medical record.

COMPLETE RESPONSE - Complete Remission
MINOR RESPONSE - Minor Response
PARTIAL RESPONSE - Partial Remission
PROGRESSIVE DISEASE - Progressive Disease
STABLE DISEASE - Stable Disease

Use pick list.

iRANO Date of actual progression

Enter the date of disease progression response status based on iRANO criteria for Glioblastoma.

DD-MMM-YYYY

RANO Progression date

Enter the the date of progression response based on Response Assessment in Neuro-Oncology Criteria Response (RANO) criteria for Glioblastoma.

DD-MMM-YYYY

Validations - TBD

Code	Description	Resolutions
CAS02, CAS03	Date of Response or Onset Date of Progress must not be future dates.	Change the date to a value no later than the current date.
CAS05	Response Notes entered and Response Assessment is different than "Not Evaluable" and "Not Assessed".	Remove the Response Notes if Response Assessment is different than "Not Evaluable" and "Not Assessed". Otherwise change the Response Assessment to "Not Evaluable" and "Not Assessed".
CAS06	Response Assessment is "Not Evaluable" or "Not Assessed" and no Response Notes were entered.	Enter the Response Notes if Response Assessment is "Not Evaluable" or "Not Assessed". Otherwise change the Response Assessment to a selection other than "Not Evaluable" and "Not Assessed".
CAS07	Date of Response is required when Response Assessment is CR, PR, MR, SD, or DU.	Enter the Date of Response or Review the Response Assessment.
CAS08	Date of Progression is required when Response Assessment is PD.	Enter the Date of Progression or Review the Response Assessment.
CAS09	Course Assessment marked as having adverse events, but there are no adverse events with an onset date that falls within this course start and end dates.	Change the field "Any Adverse Events in this Course?" to "NO" if no related adverse events exist. Otherwise enter the appropriate adverse events or adjust the appropriate adverse events dates.
CAS10	Course Assessment marked as not having adverse events, but there is at least one adverse event with an onset date that falls within this course start and end dates.	Change the field "Any Adverse Events in this Course?" to "YES" if the related adverse events are appropriate. Otherwise remove the adverse events or correct the adverse events dates.

Derivations

Code	Field Name	Description
CAS1001	Start Date of Course	The Start Date of Course entered in the Course Initiation case report form.
CAS1002	End Date of Course	The day before the start date of the following course or the off treatment date.