This phase II trial studies the effect of short-course radiation therapy and combination chemotherapy in treating patients with rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI), 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 short-course radiation therapy and FOLFOXIRI may increase the chance of the tumor completely going away, and ultimately lead to omission of surgery in patients with rectal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04380337.
PRIMARY OBJECTIVE:
I. To assess clinical complete response (cCR) of an organ preservation approach for non-metastatic, > T2N0 or low T2N0 rectal cancer using short course radiation (SCRT) followed by intensified chemotherapy.
SECONDARY OBJECTIVES:
I. To assess safety in all patients and local regrowth rate and other cancer specific outcomes (disease-free survival [DFS], colostomy-free survival and overall survival [OS]) among patients assigned to organ preservation approach.
II. To assess longitudinal functional outcomes and health-related quality of life (HRQOL) of this organ preservation approach.
OUTLINE:
Patients undergo radiation therapy daily for 6 days for a total of 6 fractions in the absence of disease progression or unacceptable toxicity. After 2-4 weeks, patients receive oxaliplatin intravenously (IV), leucovorin IV, and irinotecan IV on day 1, and fluorouracil IV over 48 hours beginning day 1. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who have performance status or conditions that may preclude use of FOLFOXIRI may be treated with oxaliplatin, leucovorin, and fluorouracil (FOLFOX) or oxaliplatin and capecitabine (XELOX) instead at the discretion of the treating physician. For the FOLFOX regimen, patients receive oxaliplatin IV and leucovorin IV on day 1, and fluorouracil IV over 46 hours beginning day 1. Treatment with FOLFOX repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. For the XELOX regimen, patients receive oxaliplatin IV on day 1 and capecitabine orally twice daily on days 1-14. Treatment with XELOX repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 3-6 months for 3 years.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorErqi Pollom
