Comparing radical and local surgery for rectal cancer after treatment
Comparing the Oncologic Efficacy of Radical Versus Local Excision for Rectal Cancer With Clinically Complete Remission to Neoadjuvant Chemoradiation Therapy: A Randomized Controlled Clinical Trial
NA · National Taiwan University Hospital · NCT05964530
This study is testing whether patients with rectal cancer who respond well to treatment can safely have less invasive surgery instead of more extensive surgery to see if it improves their recovery and quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05964530 on ClinicalTrials.gov |
What this trial studies
This project aims to improve the selection of rectal cancer patients who have achieved a pathological complete response (pCR) after preoperative chemoradiation therapy. By quantifying circulating tumor DNA (ctDNA) alongside traditional diagnostic methods, patients will be randomized into two groups: one receiving radical surgery and the other local excision. The study will compare the oncologic outcomes of these two surgical approaches, with the hypothesis that accurately predicting pCR could allow for less invasive surgery, thereby enhancing patients' quality of life post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with rectal adenocarcinoma who have completed neoadjuvant chemoradiotherapy and show no residual malignancy on imaging.
Not a fit: Patients with residual malignancy detected by ctDNA quantification or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive surgical options for rectal cancer patients, improving their quality of life.
How similar studies have performed: While the approach of using ctDNA for patient selection is innovative, similar studies have shown promise in improving surgical outcomes for rectal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. rectal adenocarcinoma completed nCRT and the imaging studies showed no residual malignancy; 2. physical status is within American Society of Anesthesiology（ASA）class Ⅰ to Ⅲ; 3. the lesion side can be reached by the transanal local excision, generally within 6 cm above anal verge; 4. age is 18-75 years. Exclusion Criteria: 1. Quantification of ct DNA shows residual malignancy; 2. Body mass index（BMI）\>40 kg/m2; 3. Previous abdominal or pelvic surgery; 4. abnormal hepatologic (Bil\>2.0 mg/dl), renal (Cre≧2.0) and hematologic(WBC\<3000, HB\<8.0, platelet\<50000) profiles after CCRT.
Where this trial is running
Taipei
- Jin-Tung LIANG — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Jin-Tung LIANG, MD
- Email: jintung@ntu.edu.tw
- Phone: +886-972654554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Cancer, Rectal cancer, Concomitant chemoradiation therapy, Radical surgery, Local excision