Planned Non-operative Management for Rectal Cancer
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
The investigators propose to conduct an observational study on consecutive patients with
low-lying or mid rectal cancers smaller than 5 cm in length and less than 50% of rectal
circumferential extent. The aim of this study is to test a hypothesis that escalation of
either radiation or chemotherapy dose of the routine preoperative radio(chemo)therapy leads
to an increase of clinical complete response rate. The planned sample size of 23 patients was
calculated based on the assumption that clinical complete response rate after routine
preoperative radio(chemo)therapy is 34% [1] and expected rate after radio(chemo)therapy dose
escalation is 75% [2-4]. An endorectal high dose rate iridium brachytherapy boost (2
fractions of 10 Gy) will be added after the routine preoperative treatment consisted of
external beam radiotherapy (5 × 5 Gy) combined with sequential 3 cycles of consolidation
FOLFOX4. However, for patients with involvement of the anal canal, additional 3 cycles of
consolidation FOLFOX4 (6 cycles in total) will be added instead of brachytherapy boost to
avoid severe post-radiation toxicity.
Phase:
Phase 2
Details
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology