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
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
Patients who prefer radical rectal resection
Prior history of surgery for rectal cancer
Recurrent rectal cancer
Synchronous metastatic rectal cancer
Parallel
TNT with additional consolidation chemotherapy followed by local excision
Drug5-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
Drug5-FU based CCRT: 5 weeks Rest period: 10 weeks Local excision
Pathologic complete response rate (ypT0)
Pathologic complete response of the primary tumor after neoadjuvant therapy
5-year Survival Rate
5-year Overall survival \& 5-year Recurrence free survival
Low anterior resection syndrome (LARS)
0-20, no / 21-29, minor / 30-42, major
EORTC-QLQ, C30 score
Quality of life surveillance
Total medical costs
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.
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This trial is not recruiting at the moment. You can still explore other options:
