When is the best time for chemoradiation before rectal cancer surgery?
NCT ID NCT00335816
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests how well chemoradiation (using fluorouracil, leucovorin, and oxaliplatin) works before surgery for stage II or III rectal cancer. The study looks at different time intervals between chemoradiation and surgery to see which timing leads to the best tumor shrinkage and fewest complications. About 248 participants are enrolled at Memorial Sloan Kettering Cancer Center.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fluorouracil, leucovorin calcium, oxaliplatin, radiation therapy
- What this could lead to
- If successful, this could help doctors choose the best time between chemoradiation and surgery to improve tumor shrinkage and reduce side effects.
- What could go wrong
- This is a mid-stage trial with 248 participants, so results may not apply to all patients. The treatment involves strong chemotherapy and radiation, which can cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 248 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2008
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * Serum creatinine =\< 1.5 times ULN * Patients with hereditary non-polyposis colorectal cancer are eligible for the study provided they meet the rest of the eligibility criteria * Patients who have experienced a prior malignancy should have received potentially curative therapy for that malignancy, and should be cancer-free for at least five years from the date of initial diagnosis (Exceptions: patients treated for basal cell carcinoma, or carcinoma in-situ of the cervix) * Patients of reproductive potential should agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects; all female participants of childbearing potential must have a negative urine or serum pregnancy test within two weeks prior to study registration * Patients or the patient's legally acceptable representative must provide written authorization to allow the use and disclosure of protected health information; NOTE: this may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration or the initiation of any study-specific procedures
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cancer Care Center at John Muir Health - Concord Campus
Concord, California, 94524-4110, United States
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Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, 92868, United States
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City of Hope Medical Center
Duarte, California, 91010-3000, United States
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Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
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Colon and Rectal Surgery, Incorporated
Omaha, Nebraska, 68114, United States
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H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497, United States
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Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098, United States
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455, United States
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Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110, United States
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St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, 92868-3849, United States
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Tom Baker Cancer Centre - Calgary
Calgary, Alberta, T2N 4N2, Canada
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
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University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
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Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05405-0110, United States
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Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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Other studies related to the condition(s) this trial covers.
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