Phase II-III Study Tailoring Treatment for Locally Advanced Rectal Cancer Based on Early Response to Induction Chemotherapy

What this Trial Is About

Researchers are studying locally advanced rectal carcinoma, a type of rectal cancer that poses challenges in controlling the disease and managing treatment side effects. Surgery alone cures only about half the patients, while radiochemotherapy improves local control but still leaves a 30% risk of metastasis and increased postoperative issues. This trial aims to personalize treatment based on the tumors early response to induction chemotherapy, measured by MRI volume changes, to better tailor therapy for good and poor responders. The trial includes an induction chemotherapy phase using a modified FOLFIRINOX regimen delivered every 15 days for six cycles. Early tumor response is evaluated by MRI two weeks after chemotherapy completion. Patients classified as very good responders will be randomly assigned to one of two study groups one undergoing immediate proctectomy surgery within 4 to 6 weeks, and the other receiving radiochemotherapy with capecitabine combined with radiotherapy over 5 weeks followed by surgery after 7 weeks. The proctectomy can be performed via laparoscopic or conventional surgery. Participants will undergo assessments including MRI scans, pathology analysis after surgery, and quality of life questionnaires over one year. Researchers will monitor surgical outcomes, disease-free survival at 3 years, local and distant recurrence rates, adverse events, and functional outcomes such as urinary and sexual function. The study plans to recruit approximately 430 patients to evaluate both surgical quality and long-term effectiveness of this personalized treatment approach.

Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma