A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)
- To determine if pelvic intensity-modulated radiation therapy (IMRT) reduces acute
gastrointestinal toxicity in the 5th week (after 23-25 fractions) of pelvic radiation
as measured with the expanded prostate cancer index composite (EPIC) instrument.
- To determine if grade 2+ gastrointestinal toxicity (Common Terminology Criteria for
Adverse Events version 4.0 [CTCAE v. 4.0]) is reduced with IMRT compared to
conventional whole-pelvis radiation therapy (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
- To assess the impact of pelvic IMRT on quality of life using the Functional Assessment
of Cancer Therapy-General (FACT-G) with cervix subscale.
- To determine if there is any difference in local-regional control, disease-free
survival, and overall survival between patients treated with IMRT as compared to
- To perform a health-utilities analysis to measure the financial impact of pelvic IMRT
via the EQ-5D instrument.
- To identify molecular predictors of radiation toxicity and novel circulating cancer
OUTLINE: This is a multicenter study. Patients are stratified according to type of cancer
(endometrial vs cervical), chemotherapy (none vs 5 courses of weekly cisplatin at 40 mg/m²),
and radiation dose (45 Gy vs 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo standard (3-dimensional) radiation therapy 5 days a week for up
to 5-6 weeks.
- Arm II: Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for
up to 5-6 weeks.
Some patients receive cisplatin IV over 1 hour on day 1. Treatment continues weekly for 5
weeks, concurrently with radiation therapy, in the absence of unacceptable toxicity or
Tissue and blood samples may be collected for biomarker and correlative analysis.
Quality of life may be assessed by questionnaires (including the Expanded Prostate Cancer
Index Composite [EPIC], the Functional Assessment of Cancer Therapy-General [FACT-G, Version
4], the EQ-5D, and the Common Toxicity Criteria Adverse Events - Patient-Reported Outcome
[PRO-CTCAE]) instruments at baseline and periodically during and after study therapy.
After completion of study therapy, patients are followed every 6 months for the first 2
years and then annually for 5 years.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute gastrointestinal toxicity, as measured by bowel domain of EPIC, at 5 weeks from the start of pelvic radiation
Week 5 of Radiation Therapy (RT)
Ann Klopp, MD, PhD
M.D. Anderson Cancer Center
United States: Federal Government
|Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|Universtiy of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|