Total Neoadjuvant Therapy With Additional Consolidation Chemotherapy Followed by Local Excision Versus Total Neoadjuvant Therapy Followed by Local Excision at Stage I Rectal Cancer

Starting soon · Not applicable

Conditions studied: Organ Preservation, Rectal Cancer Stage I, Total Neoadjuvant Treatment, Consolidation Therapy, Capecitabine

In brief

Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial The goal of this clinical trial is to find out if adding consolidation chemotherapy with capecitabine after total neoadjuvant chemoradiotherapy (TNT) works to improve oncologic outcomes in patients with stage I rectal cancer. It will also comparethe safety of adding consolidation chemotherapy before local excision. The main questions it aims to answer are: * Does adding consolidation chemotherapy increase the rate of pathologic complete response? * What medical problems or side effects do participants have during and after treatment? Researchers will compare TNT followed by local excision to TNT followed by consolidation chemotherapy with capecitabine and then local excision to see if adding consolidation chemotherapy improves tumor response and treatment outcomes. Participants will: * Receive TNT for stage I rectal cancer * Be randomly assigned to one of two treatment groups * Undergo local excision after preoperative treatment * Visit the clinic for checkups and tests to evaluate tumor response, side effects, recurrence, survival, quality of life, bowel function, urinary function, sexual function, circulating tumor DNA, and treatment-related costs

Key facts

Study ID: NCT07563907
Run by: Seoul National University Hospital
People needed: 292
Starts: 2026-06-01
Expected to finish: 2035-12-31
Last updated by the study team: 2026-05-04

Who can join

Age: 19 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed rectall adenocarcinoma
Low rectal cancer (AV < 15cm)
cT2N0 disease, or pathologic stage T1N0 disease after endoscopic resection with at least one high-risk feature, including: Positive resection margin Lymphovascular invasion Tumor budding ≥5
Ability to understand and comply with the requirements of the clinical trial

You may not qualify if…

Patients who prefer radical rectal resection
Prior history of surgery for rectal cancer
Recurrent rectal cancer
Synchronous metastatic rectal cancer
Evidence of lymph node metastasis or distant metastasis on abdominopelvic CT or chest CT, including para-aortic, common iliac, or external iliac lymph node metastasis
Uncontrolled active infection or other uncontrolled medical condition
Known hypersensitivity to chemotherapy
Patients considered unsuitable for participation in the clinical trial by the principal investigator or study personnel

Where it is running

Seoul National University Hospital — Seoul, Jongro-gu, South Korea

Full record on ClinicalTrials.gov

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