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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
Field Name | Description / Instructions | Format |
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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.
| 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.
| 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 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 | 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 |
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Field Name | Description / Instructions | Format | |
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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. | 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: | 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.
| 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 | 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:
| 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
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. | 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 | 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 |
Code | Description | Resolutions |
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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. |
Code | Field Name | Description |
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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. |