Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06949098
PHASE2

Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer

Sponsor: Hebei Medical University Fourth Hospital

View on ClinicalTrials.gov

Summary

This study is a single-center, single-arm, prospective clinical trial designed to evaluate the efficacy of local excision followed by postoperative chemoradiotherapy in patients with early-stage low/ultra-low rectal cancer. The study plans to enroll 60 patients with T1-2N0M0 low/ultra-low rectal cancer.

Official title: An Exploratory Study of Local Resection Combined With Chemoradiotherapy in Patients With Low/Ultra-low Early-stage Rectal Cancer With a Strong Desire to Preserve the Anus

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-05-15

Completion Date

2032-05

Last Updated

2025-05-29

Healthy Volunteers

No

Interventions

PROCEDURE

Local Tumor Resection

All enrolled patients will first undergo local tumor resection.

RADIATION

Radiotherapy

Pelvic field irradiation 45Gy in 25 fractions plus Local tumor bed boost 5.4Gy in 3 fractions. For patients with positive surgical margins after local resection, a radiotherapy boost (pelvic field 45Gy/25 fractions + tumor bed local boost 14.4Gy/8 fractions) can be given.

DRUG

Chemotherapy

Concurrent oral capecitabine 825 mg/m² twice daily with radiotherapy

Locations (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China