Radical vs Local Excision for Rectal Cancer With Clinically Complete Remission

Recruiting now · Not applicable

Conditions studied: Rectal Cancer

In brief

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), taking advantage of quantification of circulating tumor DNA (ctDNA) in addition to the current available diagnostic modalities, including CT, MRI, PET and colonoscopy. The patients with suspected pCR to CCRT will be randomized to radical surgery and local excision groups, followed by the comparison of the oncologic outcomes between two treatment methods. The investigators hypothesized that if the pCR for patients with rectal cancer after CCRT can be more accurately predicted, such patients can be safely treated with limited surgery to enhance the post-treatment life quality, in comparison with patients undergoing radical surgery.

Key facts

Study ID

NCT05964530

Run by

National Taiwan University Hospital

People needed

180

Starts

2023-04-19

Expected to finish

2026-10-19

Last updated by the study team

2024-09-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Jin-Tung LIANG — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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