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 ClinicalTrials.gov)
DFCI Protocol ID: 12-023

 

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.

 

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

Contacts:
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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