Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer

Running, not enrolling · Phase 2

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00335816

Run by

Memorial Sloan Kettering Cancer Center

People needed

248

Starts

2008-08-01

Expected to finish

2026-12-01

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1, or comparable Karnofsky performance status
• Patients must have histologically confirmed invasive adenocarcinoma of the rectum Distal border of the tumor must be within 12 cm from the anal verge as measured on rigid proctoscopic exam
• Patients must have Stage II (uT3-4, uN0) or Stage III (any T, uN1-2) tumors, as confirmed by ERUS or MRI; females with anterior tumors invading the posterior vaginal wall (uT4) and males with anterior tumors that invade the seminal vesicles or adjacent organs (uT4) will also be eligible provided they undergo an extended resection including the organs involved
• Patients with high grade obstruction that impedes the ERUS exam are eligible for the study provided they can be staged by MRI
• Patients with synchronous or metachronous colorectal cancer are eligible for the study on condition that they are treated for rectal cancer in accordance with the protocol
• Patients with the following are NOT allowed on study:
• Metastatic disease or other primaries
• Locally recurrent rectal cancer
• Previously documented history of Familial Adenomatous Polyposis
• History of Inflammatory Bowel Disease
• History of prior radiation treatments to pelvis
• History of clinically significant cardiac disease (i.e., Class 3-4 congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, and/or myocardial infarction within the previous 6 months
• History of uncontrolled seizures or clinically significant central nervous system disorders
• History of psychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance
• History of allergy and/or hypersensitivity to 5-fluorouracil (fluorouracil), leucovorin (leucovorin calcium), and/or oxaliplatin
• History of difficulty or inability to take or absorb oral medications
• Patients must have adequate bone marrow, hepatic and renal function within 7 days prior to registration
• White blood cells (WBC) >= 3,000 mm\^3
• Absolute neutrophil count (ANC) > 1,500 mm\^3
• Hemoglobin > 9.5 mg/dl
• Platelet count >= 100,000 mm\^3
• Total bilirubin =< 1.5 mg/dl
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.0 times institutional upper limit of normal (ULN)
• Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.0 times ULN
• Alkaline phosphatase =< 2.0 times ULN

Where it is running

• 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

Full record on ClinicalTrials.gov

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