Duration of Response Duration of overall response: The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented. Duration of stable disease: Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progression-Free Survival Include this section if time to progression or progression-free survival (PFS) is to be used. PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Response Review For trials where the response rate is the primary endpoint, it is strongly recommended that all responses be reviewed by an expert(s) independent of the study at the study’s completion. Simultaneous review of the patients’ files and radiological images is the best approach. Antitumor Effect Hematologic Tumors – Please provide appropriate criteria for evaluation of response and methods of measurement. Add subsections as needed. Other Response Parameters Other endpoints and the criteria for their measurement should be entered below or reference should be made to the protocol section where these criteria may be found. Add subsections as needed. STUDY OVERSIGHT AND DATA REPORTING / REGULATORY REQUIREMENTS Adverse event lists, guidelines, and instructions for AE reporting can be found in Section 10 (Adverse Events: List and Reporting Requirements). Study Oversight
Duration of Response Duration of overall response: The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented. Duration of stable disease: Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progression-Free Survival Include this section if time to progression or progression-free survival (PFS) is to be used. PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Response Review For trials where the response rate is the primary endpoint, it is strongly recommended that all responses be reviewed by an expert(s) independent of the study at the study’s completion. Simultaneous review of the patients’ files and radiological images is the best approach. Antitumor Effect – Hematologic Tumors Please provide appropriate criteria for evaluation of response and methods of measurement. Add subsections as needed. Other Response Parameters Other endpoints and the criteria for their measurement should be entered below or reference should be made to the protocol section where these criteria may be found. Add subsections as needed. STUDY OVERSIGHT AND DATA REPORTING / REGULATORY REQUIREMENTS Adverse event lists, guidelines, and instructions for AE reporting can be found in Section 10 (Adverse Events: List and Reporting Requirements). Study Oversight
CTEP_Organ_Dysfunction_Protocol_Template.docx