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NOT YET RECRUITING
NCT07786493
NA

HDR Endorectal Brachytherapy With 3D-Printed Guidance and Local Shielding for Rectal Cancer Organ Preservation

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This prospective, single-center, single-arm phase II study will evaluate the efficacy, safety, and technical feasibility of an organ-preserving radiotherapy strategy for patients with localized rectal adenocarcinoma who are medically inoperable, decline radical surgery, or are considered technically unresectable without distant metastases. Participants will receive pelvic external beam radiotherapy followed by high-dose-rate (HDR) endorectal brachytherapy. Concurrent capecitabine may be given during external beam radiotherapy to participants who are considered able to tolerate chemotherapy. During HDR brachytherapy, all participants will be treated using a patient-specific 3D-printed guide template and individualized tungsten-alloy local shielding. The guide template is designed to improve applicator positioning and treatment reproducibility, while the local shielding is intended to reduce radiation exposure to non-target rectal wall. The study will enroll 50 participants. The primary objectives are to evaluate the 12-month clinical complete response rate and the technical completion rate of the HDR brachytherapy platform. Secondary assessments include organ preservation, local regrowth, survival outcomes, treatment-related toxicity, quality of life, and anorectal function.

Official title: A Prospective Single-Arm Phase II Study of Pelvic External Beam Radiotherapy Followed by HDR Endorectal Brachytherapy Combined With a 3D-Printed Individualized Guide Template and Tungsten-Alloy Local Shielding for Organ Preservation in Inoperable Localized Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-09-01

Completion Date

2030-11-30

Last Updated

2026-08-26

Healthy Volunteers

No

Interventions

RADIATION

High-Dose-Rate Endorectal Brachytherapy

High-dose-rate (HDR) endorectal brachytherapy will be delivered as a local dose-intensification component of the organ-preserving treatment strategy for rectal cancer. Brachytherapy will be performed using image-guided, patient-specific treatment planning to optimize target coverage while limiting radiation exposure to adjacent organs at risk. Treatment technique, applicator placement, dose prescription, and fractionation will be performed according to the study protocol.

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China