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Uterine Cervix, and Endometrial

A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)

Unique Dataset IDnci-data-418ClinicalTrial.gov IDNCT01672892
DownloadableNo
SponsorRadiation Therapy Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients289RandomizationYesPubMed (PMID)29989857.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeRadiationDataset TypeOther

Clinical Trial Title

A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)

Trial Summary and Conditions

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.

Data Summary

See Data Dictionary.

Study 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.

Outcome Measures

Primary: Acute Gastrointestinal Toxicity. Secondary: Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment; Urinary Toxicity; Quality of Life; Health Utilities; Local-regional Recurrence; Disease-free Survival; Overall Survival; Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers; Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains; Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains; Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score; Mean Change From Baseline in EPIC Bowel and Urinary Domain.

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

This dataset contains patient-reported acute toxicity and health-related quality of life (QOL) data from trial NCT01672892 to reproduce the results in PubMed ID=29989857.

Available Downloads: NCT01672892-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01672892-D1-Data-Dictionary_2.pdf

DATA: NCT01672892-D1-Dataset_1.csv

OTHER: README.pdf