Evaluating Short Course Radiation and Combination Chemotherapy for Stage II-III Rectal Cancer to Preserve Organs and Improve Outcomes

What this Trial Is About

Researchers are evaluating how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. This phase I trial focuses on using radiation to kill tumor cells and shrink tumors, along with chemotherapy drugs such as leucovorin, fluorouracil, oxaliplatin, and capecitabine that aim to stop tumor growth. The goal is to reduce the need for surgery and improve quality of life for patients with locally advanced rectal adenocarcinoma. Participants receive intensity-modulated radiation therapy IMRT over five consecutive days. Starting 11 to 18 days after radiation, they then receive combination chemotherapy with either mFOLFOX6 oxaliplatin and leucovorin intravenously, fluorouracil intravenously or CapeOX oxaliplatin intravenously and oral capecitabine. Treatment cycles last up to 16 weeks, with mFOLFOX6 repeating every two weeks for up to eight cycles and CapeOX every three weeks for up to six cycles, depending on tolerance and disease progression. After treatment, patients with remaining tumor undergo total mesorectal excision TME surgery, while those with complete clinical response cCR follow a non-operative management NOM approach. During the study, patients are monitored through imaging, laboratory tests, and health-related quality of life assessments. Follow-up includes regular visits every three months for two years, then every six months for three years for NOM patients TME patients have follow-ups every three to six months for two years, then every six months for three years. Researchers measure outcomes such as complete clinical response rates, local recurrence-free survival, progression-free survival, adverse events, anorectal function, and quality of life. They also explore predictive markers using MRI and residual disease tests to better understand treatment effects over up to five years.

Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer