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Radical vs Local Excision for Rectal Cancer With Clinically Complete Remission

NCT05964530 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-09-20

No results posted yet for this study

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), 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.

Conditions

Interventions

PROCEDURE

Surgery

Surgery procedures include LAR+ anal preservation or APR

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Jin-Tung LIANG, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2026-04-19
Completion
2026-10-19

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05964530 on ClinicalTrials.gov