Phase 3 Study Comparing Chemotherapy Alone Versus Chemotherapy with Radiation Before Surgery in Early Rectal Cancer

What this Trial Is About

Researchers are evaluating whether the chance of rectal cancer responding is the same when chemotherapy alone is given before limited surgery compared to chemotherapy combined with radiation therapy before limited surgery. This study focuses on early rectal cancer and aims to find out if the new approach is better or worse than the usual treatment, which typically involves surgery or chemotherapy plus radiation before surgery. About 90% of patients receiving standard care are free of cancer after 5 years. Participants will receive either chemotherapy alone with drugs called FOLFOX or CAPOX for up to 12 weeks or chemotherapy combined with radiation therapy for up to 6 weeks before surgery. The chemotherapy drugs include leucovorin, oxaliplatin, fluorouracil, and capecitabine. Radiation therapy is given as 54 Gy over 27-30 sessions. After treatment, the study doctor will monitor side effects and decide on the best type of surgery. Surgery is followed by regular check-ups. During the study, patients will visit the doctor every 4 months for 2 years, then every 6 months for one year, and then annually for 2 more years, totaling up to 5 years of follow-up after surgery. Assessments will include quality of life using the LARS score and clinical response rates. Other evaluations involve bowel and bladder function, adverse events, and tumor response using MRI. This long-term monitoring helps understand treatment effects and patient well-being over time.

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer