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Not yet recruiting 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

No phase Interventional Organ Preservation Rectal Cancer Stage I Total Neoadjuvant Treatment Consolidation Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TNT with additional consolidation chemotherapy followed by local excision, TNT followed by local excision.
Who it may be relevant to
Registry conditions: Organ Preservation, Rectal Cancer Stage I, Total Neoadjuvant Treatment, Consolidation Therapy. Basic parameters: 19 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug TNT with additional consolidation chemotherapy followed by local excision
    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
  • Drug TNT followed by local excision
    5-FU based CCRT: 5 weeks Rest period: 10 weeks Local excision

Primary outcome measures

  • Pathologic complete response rate (ypT0) [Time frame: At pathologic assessment of the local excision specimen, approximately 10 weeks after completion of TNT]
Secondary outcome measures (4)
  • 5-year Survival Rate [Time frame: 5 years]
  • Low anterior resection syndrome (LARS) [Time frame: After local excision]
  • EORTC-QLQ, C30 score [Time frame: After local excision, 4weeks]
  • Total medical costs [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT07563907 · 2603-018-1725

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗