Status:
RECRUITING
Radical vs Local Excision for Rectal Cancer With Clinically Complete Remission
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In the present project, the investigators plan to more accurately select the rectal cancer patients with pathological complete response (pCR) to preoperative concomitant chemoradiation therapy (CCRT),...
Detailed Description
In Taiwan, patients with stage Ⅱ or Ⅲ rectal cancer represented around 30% of all cases of colorectal cancer(n=15,000 annually). Standard treatment of locally advanced rectal cancer consists of neoadj...
Eligibility Criteria
Inclusion
- rectal adenocarcinoma completed nCRT and the imaging studies showed no residual malignancy;
- physical status is within American Society of Anesthesiology（ASA）class Ⅰ to Ⅲ;
- the lesion side can be reached by the transanal local excision, generally within 6 cm above anal verge;
- age is 18-75 years.
Exclusion
- Quantification of ct DNA shows residual malignancy;
- Body mass index（BMI）\>40 kg/m2;
- Previous abdominal or pelvic surgery;
- abnormal hepatologic (Bil\>2.0 mg/dl), renal (Cre≧2.0) and hematologic(WBC\<3000, HB\<8.0, platelet\<50000) profiles after CCRT.
Key Trial Info
Start Date :
April 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 19 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05964530
Start Date
April 19 2023
End Date
October 19 2026
Last Update
September 20 2024
Active Locations (1)
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1
Jin-Tung LIANG
Taipei, Taiwan, 100