Phase I Trial of Dose-escalation Preoperative Short-course Radiotherapy (5x6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy in Locally Advanced Rectal Cancer The FJUHR-01 Trial

What this Trial Is About

Researchers are evaluating a new approach for treating locally advanced rectal cancer by testing different doses of short-course radiotherapy (SCRT) followed by chemotherapy. The study aims to find the safest and most effective dose escalation of SCRT (5x6Gy, 7Gy, or 8Gy per fraction) combined with four cycles of modified FOLFOX6 chemotherapy to improve treatment outcomes. This approach is based on previous findings that SCRT shortens treatment time and reduces costs but has lower pathological complete response (pCR) rates compared to long-course radiotherapy. Participants receive preoperative short-course radiotherapy with escalating doses of radiation in groups, followed by four cycles of mFOLFOX6 chemotherapy before surgery. The radiation doses will increase stepwise from 6Gyx5 fractions to 8Gyx5 fractions using a traditional dose escalation design. This study includes three groups corresponding to each radiation dose level, and the safety and effectiveness of this combined treatment will be assessed. During the study, participants will undergo assessments to measure the pathological complete response rate, tumor removal success (R0 resection), sphincter preservation, surgical complications, and acute toxicities from radiation and chemotherapy. These evaluations occur four weeks after surgery and up to three months post-treatment. The study follows patients from preoperative treatment through surgery and recovery to monitor treatment effects and safety over this period.

Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer