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Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Fluorouracil may also make tumor cells more sensitive to radiation therapy. Leucovorin calcium may protect normal cells from the side effects of chemotherapy, and it may help fluorouracil work better by making tumor cells more sensitive to the drug. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy together with fluorouracil with or without combination therapy works in treating patients who are undergoing surgery for stage II or stage III rectal cancer.
Official title: Timing of Rectal Cancer Response to Chemoradiation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2008-08
Completion Date
2026-12
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
fluorouracil
Given IV
leucovorin calcium
Given IV
oxaliplatin
Given IV
conventional surgery
Patients undergo surgery
radiation therapy
Patients undergo radiotherapy
laboratory biomarker analysis
Correlative studies
DNA analysis
Correlative studies
polymerase chain reaction
Correlative studies
immunohistochemistry staining method
Correlative studies
Locations (15)
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States
City of Hope Medical Center
Duarte, California, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Colon and Rectal Surgery, Incorporated
Omaha, Nebraska, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada