Return to Clinical Trials Search Results
A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)
Primary Objectives
To determine if IMRT reduces acute gastrointestinal toxicity in the 5th week (after 23-25 fractions)
of pelvic radiation as measured with EPIC.
Secondary Objectives
To determine if grade 2+ gastrointestinal toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional WPRT
To determine if grade 2+ hematologic toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional WPRT
To determine if urinary toxicity is reduced with IMRT using the EPIC urinary domain
To validate EPIC bowel and urinary domains in women undergoing either IMRT pelvic radiation treatment or four field pelvic radiation treatment for endometrial or cervical cancer
To assess the impact of pelvic IMRT on quality of life using the FACT-G with cervix subscale
To determine if there is any difference in local-regional control, disease-free survival, and overall survival with IMRT as compared to conventional pelvic RT
To perform a health utilities analysis to measure the financial impact of pelvic IMRT
To identify molecular predictors of radiation toxicity and novel circulating cancer biomarkers
To determine if there is any difference in rate of secondary cancers with IMRT as compared to conventional pelvic RT
Primary Objectives
To determine if IMRT reduces acute gastrointestinal toxicity in the 5th week (after 23-25 fractions)
of pelvic radiation as measured with EPIC.
Secondary Objectives
To determine if grade 2+ gastrointestinal toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional WPRT
To determine if grade 2+ hematologic toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional WPRT
To determine if urinary toxicity is reduced with IMRT using the EPIC urinary domain
To validate EPIC bowel and urinary domains in women undergoing either IMRT pelvic radiation treatment or four field pelvic radiation treatment for endometrial or cervical cancer
To assess the impact of pelvic IMRT on quality of life using the FACT-G with cervix subscale
To determine if there is any difference in local-regional control, disease-free survival, and overall survival with IMRT as compared to conventional pelvic RT
To perform a health utilities analysis to measure the financial impact of pelvic IMRT
To identify molecular predictors of radiation toxicity and novel circulating cancer biomarkers
To determine if there is any difference in rate of secondary cancers with IMRT as compared to conventional pelvic RT
Recruitment Status
Past Studies