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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Jin-Tung LIANG
RECRUITING
Taipei
Contact Information
Primary
Jin-Tung LIANG, MD
jintung@ntu.edu.tw
+886-972654554
Time Frame
Start Date: 2023-04-19
Estimated Completion Date: 2026-10-19
Participants
Target number of participants: 180
Treatments
Experimental: Watch and wait group
In this group, the patients with clinically complete response will undergo non-surgical treatment (watch-and-wait group)
Active_comparator: Surgical group
In this group, the patients with clinically complete response will undergo surgical treatment (LAR with anal preservation or APR)
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov