NCT07563907Not yet recruiting
Total Neoadjuvant Therapy With Additional Consolidation Chemotherapy Followed by Local Excision Versus Total Neoadjuvant Therapy Followed by Local Excision at Stage I Rectal Cancer
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
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 292 (estimated)
- First submitted
- 26 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07563907
What you commit to
- Study type: Interventional
- Planned participants: 292
- From 1 Jun 2026 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who prefer radical rectal resection
- Prior history of surgery for rectal cancer
Other illness
- Recurrent rectal cancer
- Synchronous metastatic rectal cancer
- Uncontrolled active infection or other uncontrolled medical condition
- Known hypersensitivity to chemotherapy
Other
- 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
- Patients considered unsuitable for participation in the clinical trial by the principal investigator or study personnel
Who the study is looking for
- 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
Age in the registry: 19 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.