N1048 PROSPECT**) A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiaiton Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
Description: 

The study investigators hypothesize that neoadjuvant FOLFOX can safely and efficaciously be delivered as an alternative 5FUCMT without compromising either the ability to perform a pelvic R0 resection, the local control rate or overall disease free survival for appropriately selected locally advanced rectal cancer patients who are treatedwith contemporary surgical technique including TME and contemporary FOLFOX chemotherapy. We further hypothesize that early administration of FOLFOX will provide N1048 Addendum 4 13optimal systemic therapy for any clinically occult micrometastases which may be present, and that pre-operative elimination of radiation to select patients will allow more complete delivery of post-operative FOLFOX. We anticipate that this strategy will minimize toxicity and optimize outcomes for appropriately selected locally advanced rectal cancer patients.

Study Number: 

NCG 236313

Phase: 
II/III
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT01515787

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