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NCT Number: NCT07563907

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

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

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Key information

Conditions

Organ Preservation Capecitabine Colorectal Neoplasms Consolidation Therapy Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Stage I Rectal Diseases Rectal Neoplasms Total Neoadjuvant Treatment

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Jongro-gu, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 followed by local excision

Drug

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

Primary outcomes

  1. Pathologic complete response rate (ypT0)

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

    Pathologic complete response of the primary tumor after neoadjuvant therapy

Secondary outcomes

  1. 5-year Survival Rate

    Time frame: 5 years

    5-year Overall survival & 5-year Recurrence free survival

  2. Low anterior resection syndrome (LARS)

    Time frame: After local excision

    0-20, no / 21-29, minor / 30-42, major

  3. EORTC-QLQ, C30 score

    Time frame: After local excision, 4weeks

    Quality of life surveillance

  4. Total medical costs

    Time frame: 5 years

    Total medical costs related to treatment, including chemoradiotherapy, chemotherapy, local excision, follow-up examinations, management of treatment-related complications, and additional treatment for recurrence, if applicable.

Study contacts

Contact information is provided by the study sponsor or research team.

Seung-Bum Ryoo

CONTACT

[email protected]

+82-010-3811-2516

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: OPTION

Important dates

Study start
2026
Primary completion
2030
Study completion
2035
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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