This phase II trial studies how well radiation therapy with fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX regimen) or capecitabine/oxaliplatin (CapeOx regimen) works in treating patients with stage I-IIIB rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02641691.
PRIMARY OBJECTIVES:
I. To determine the complete clinical response (cCR) response rate of patients with stage I-IIIB (cT1-3, N0-2, M0) rectal cancer being treated with sequential short course radiotherapy followed by 8 cycles of multi-drug chemotherapy.
SECONDARY OBJECTIVES:
I. To obtain prospective patient reported outcomes from an organ preservation approach for early stage rectal cancer.
II. To determine the incidence of any grade >= 3 toxicity during treatment.
III. To determine the incidence of post chemoradiotherapy grade >= 3 toxicity at 1 year.
IV. To determine quality of anorectal function at 1 year using the Functional Assessment of Cancer Therapy-Colorectal Cancer (FACT-C) questionnaire.
OUTLINE:
Patients undergo radiation therapy once daily (QD) or every other day for 5 days (Monday-Friday). Beginning 2-4 weeks after completion of radiation therapy, patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Treatment repeats every 14 days for a total of 8 courses. Patients may alternatively receive oxaliplatin IV on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for a total of 5 courses.
After completion of study treatment, patients are followed up periodically for up to 5 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorHyun Kim
