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Neoadjuvant FOLFOX therapy and active surveillance without use of radiation in locally advanced rectal cancer

Research Question:
What is the effect of neoadjuvant chemotherapy without the use of radiation and surgery on patients with locally advanced rectal cancer?

Basic Study Information

The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery. These patients will be evaluated for complete clinical response (cCR) after completing up to 10 cycles of modified FOLFOX (mFOLFOX) (fluorouracil, leucovorin, oxaliplatin) chemotherapy, with interval analysis after six cycles. Patients who have stable or progressive disease will be removed from study and treated per discretion of the treating physician. Those determined to have partial or complete response will complete full neoadjuvant treatment and undergo close surveillance with watchful waiting for local recurrence without immediate surgery. The primary endpoint of this study will be the rate of cCR, which is to include complete and near complete clinical response, with secondary endpoints of disease-free survival (DFS), overall survival (OS), quality of life (QOL), as well as evaluation of safety and toxicity.

Location: University of Rochester Medical Center
Study Reference #: UGIC18095

Lead Researcher (Principal Investigator)

Lead Researcher: Marcus Noel

Study Contact Information

Study Coordinator: Tanya Smith
Phone: (585) 275-8213

Additional Study Details

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