Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSD
Dates
study started
completion around

Description

Summary

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

Official Title

A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)

Details

Keywords

Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma, Anal Canal Squamous Cell Carcinoma, Anal Margin Squamous Cell Carcinoma, Stage I Anal Cancer AJCC v8, Stage IIA Anal Cancer AJCC v8, Carcinoma, Squamous Cell Carcinoma, Anus Neoplasms, Deoxyglucose, Capecitabine, Fluorouracil, Mitomycins, Mitomycin, Fluorodeoxyglucose F18, Biopsy, Biospecimen Collection, Computed Tomography, Fludeoxyglucose F-18, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, de-intensified chemoradiation

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ECOG-ACRIN Cancer Research Group
ID
NCT04166318
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 252 study participants
Last Updated