A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 289
- Locations
- 273
- Primary Endpoint
- Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation
Study Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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 cervical cancer.
- 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 conventional WPRT.
- 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 biomarkers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation
Time Frame: Baseline and week 5 of RT
The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.
Secondary Outcomes
- Urinary Toxicity, as Measured by Change in EPIC Urinary Domain(Baseline, week 3 and 5 of RT, and 4-6 weeks after RT)
- Overall Survival(From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.)
- Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers(Outcome measure will not be analyzed)
- Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence)(Baseline and week 5 of RT)
- Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity)(Baseline and week 5 of RT)
- Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale(Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT)
- Health Utilities, as Measured by Change From Baseline in EQ-5D(Baseline, week 5 of RT, 4-6 weeks after RT)
- Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment(Baseline to Week 5 of RT)
- Disease-free Survival(From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.)
- Local-regional Recurrence(From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.)
- Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability)(Baseline and week 5 of RT)
- Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment)(Baseline and week 5 of RT)