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Phase 2 Study on Safety and Effectiveness of Short Course Radiation and CAPOX Chemotherapy Before Surgery for T2 Rectal Cancer
Led by Osaka University · Updated on 2023-07-11
45
Participants Needed
2
Research Sites
208 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combined preoperative treatment approach for patients with cT2 rectal cancer. This phase 2, multicenter, single-arm study aims to assess how well short-course radiation therapy followed by chemotherapy works before surgery. The goal is to improve treatment outcomes for patients with this specific stage of rectal cancer. The treatment includes a short course of radiation therapy delivered as five daily doses of 5 Gy each. After radiation, patients receive six cycles of a chemotherapy regimen called CAPOX, which combines oxaliplatin and capecitabine over several weeks. Following these preoperative therapies, patients undergo surgery involving total mesorectal excision with radical lymph node removal to address the cancer. Participants will be closely monitored throughout the study to evaluate the pathological complete response, which measures the absence of cancer cells after treatment. Assessments include imaging and laboratory tests, as well as evaluations of organ function before treatment begins. The study will continue for about six months on average, during which safety and treatment effects are carefully recorded to understand the benefits and risks of this combined therapy approach.
CONDITIONS
Brief Title
A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer
Research Team
M
Mamoru Uemura, MD, PhD
Y
Yoshinori Kagawa, MD, PhD
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