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ACTIVE NOT RECRUITING
NCT06246344
PHASE3

Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

Sponsor: Shandong Cancer Hospital and Institute

View on ClinicalTrials.gov

Summary

This prospective, single-center, randomized controlled trial evaluates whether online adaptive radiotherapy (ART) with a sequential boost to both the primary rectal tumor and clinically involved lymph nodes improves pathologic complete response in patients with high-risk, node-positive locally advanced rectal cancer. Participants were randomly assigned 1:1 to online ART with a sequential boost or conventional non-adaptive intensity-modulated radiotherapy (IMRT). Both groups received concurrent capecitabine during long-course chemoradiotherapy, followed by 3-4 cycles of CAPEOX consolidation chemotherapy and planned total mesorectal excision. The planned sample size was 128 participants. Enrollment was discontinued after an interim review after 76 participants had been randomized; long-term follow-up of enrolled participants is ongoing.

Official title: Online Adaptive Radiotherapy With a Boost to the Primary Tumor and Clinically Involved Lymph Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2023-12-01

Completion Date

2030-12-01

Last Updated

2026-09-15

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Online Adaptive Radiotherapy With Sequential Boost

MR- or CBCT-guided online adaptive radiotherapy with daily imaging, target and organ-at-risk review, and plan reoptimization. A sequential boost of 9 Gy in 3 fractions or 10 Gy in 2 fractions is delivered to GTVp and GTVn, followed by 50 Gy in 25 fractions to the pelvic CTV.

RADIATION

Conventional Non-Adaptive IMRT

Conventional non-adaptive intensity-modulated radiotherapy to the pelvic CTV at 50 Gy in 25 fractions without dose escalation.

DRUG

Capecitabine

Capecitabine 825 mg/m² orally twice daily during long-course chemoradiotherapy.

DRUG

CAPEOX

Consolidation chemotherapy consisting of capecitabine 1000 mg/m² orally twice daily on days 1-14 plus oxaliplatin 130 mg/m² intravenously on day 1 every 3 weeks for 3-4 cycles after chemoradiotherapy.

PROCEDURE

Total Mesorectal Excision

Total mesorectal excision planned after completion of neoadjuvant treatment according to standard surgical principles.

Locations (1)

Department of Radiation Oncology, Shandong Cancer Hospital and Institute

Jinan, Shandong, China