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

NCT07563907 | Not Yet Recruiting DMC

• 1 other identifier: 2603-018-1725
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Organ Preservation; Rectal Cancer Stage I; Capecitabine; Total Neoadjuvant Treatment; Consolidation Therapy

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response rate (ypT0)

  Pathologic complete response of the primary tumor after neoadjuvant therapy

  At pathologic assessment of the local excision specimen, approximately 10 weeks after completion of TNT

Secondary Outcomes (4)

• 5-year Survival Rate

  5 years

• Low anterior resection syndrome (LARS)

  After local excision

• EORTC-QLQ, C30 score

  After local excision, 4weeks

• Total medical costs

  5 years

Study Arms (2)

TNT with consolidation therapy

EXPERIMENTAL

Drug: TNT with additional consolidation chemotherapy followed by local excision

TNT without consolidation therapy

ACTIVE COMPARATOR

Drug: TNT followed by local excision

Interventions

TNT with additional consolidation chemotherapy followed by local excision DRUG

5-FU based CCRT: 5 weeks Rest period: 1 week 5-FU (Capecitabine) Consolidation chemotherapy 3 cycles: 8 weeks Rest period: 1 week Local excision

TNT with consolidation therapy

TNT followed by local excision DRUG

5-FU based CCRT: 5 weeks Rest period: 10 weeks Local excision

TNT without consolidation therapy

Eligibility Criteria

• Age: 19 Years - 79 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongro-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Trinitrotoluene

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Toluene; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Seung-Bum Ryoo

CONTACT

+82-010-3811-2516; sbryoomd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

KR (1)