Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05964530

Radical vs Local Excision for Rectal Cancer With Clinically Complete Remission

Led by National Taiwan University Hospital · Updated on 2024-09-20

180

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Radical vs Local Excision for Rectal Cancer With Clinically Complete Remission

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with rectal adenocarcinoma and completed neoadjuvant chemoradiotherapy with no cancer detected on imaging
  • Physical health status within American Society of Anesthesiology (ASA) class 1 to 3
  • Tumor located within 6 cm of the anal verge, accessible for transanal local excision
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Circulating tumor DNA test indicates residual cancer after chemoradiotherapy
  • Body mass index (BMI) greater than 40 kg/m2
  • History of previous abdominal or pelvic surgery
  • Abnormal liver function (bilirubin > 2.0 mg/dl), kidney function (creatinine ≥ 2.0), or blood counts (WBC < 3000, hemoglobin < 8.0, platelet < 50000) after chemoradiotherapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Jin-Tung LIANG

Taipei, Taiwan, 100

Actively Recruiting

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Research Team

J

Jin-Tung LIANG, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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