Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery

Status: Recruiting
Phase: Phase 2/Phase 3
Diagnosis: Colorectal Cancer, Gastrointestinal Malignancies
NCT ID: NCT01515787 (View complete trial on
DFCI Protocol ID: 12-023


RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy alone is more effective then chemotherapy plus radiation therapy in treating rectal cancer. PURPOSE: This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, DF/BWCC at South Shore Hospital, Dana Farber Cancer Institute at Milford, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Rolf Freter, MD, Ph.D., Dana Farber Cancer Institute at South Shore

Site-responsible Investigators:
Deborah Schrag, MD, MPH, Dana Farber Cancer Institute
Michael Constantine, M.D., Dana Farber Cancer Institute at Milford Hosptial
David P. Ryan, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

DISEASE CHARACTERISTICS: - Diagnosis of rectal adenocarcinoma - Radiologically measurable or clinically evaluable disease - For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined-modality, neoadjuvant chemoradiation followed by curative-intent surgical resection - Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon - No patient for whom primary surgeon indicates need for abdominoperineal (APR) at baseline - Clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB) - No clinical T4 tumors - Preoperative proctoscopy with tumor tissue evident between 5 and 12 cm from the anal verge, inclusive - No evidence that tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or ERUS/pelvic CT scan - No tumor causing symptomatic bowel obstruction PATIENT CHARACTERISTICS: - ECOG performance status 0, 1, or 2 - Absolute neutrophil count (ANC) ≥ 1,500/mm³ - Platelets ≥ 100,000/mm³ - Hemoglobin > 8.0 g/dL - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 3 times ULN - Creatinine ≤ 1.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Patient of child-bearing potential is willing to employ adequate contraception - Willing to return to enrolling medical site for all study assessments - No other invasive malignancy ≤ 5 years prior to registration; exceptions are colonic polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix - No co-morbid illnesses or other concurrent disease that, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is ≥ 5 years) - No prior pelvic radiation
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