Radical vs Local Excision for Rectal Cancer With Clinically Complete Remission

NCT05964530 | Recruiting

• 1 other identifier: 202212114RIND
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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), 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

Rectal Cancer

Keywords

Rectal cancer; Concomitant chemoradiation therapy; Radical surgery; Local excision

Outcome Measures

Primary Outcomes (1)

• Overall disease-free survival

  The duration from surgical resection of primary tumor to the cancer recurrence

  3 years

Secondary Outcomes (3)

• Postoperative 30-day complications

  30 days

• The length of stay

  An average of 7 days

• Overall survival

  3 years

Study Arms (2)

Watch and wait group

EXPERIMENTAL

In this group, the patients with clinically complete response will undergo non-surgical treatment (watch-and-wait group)

Procedure: Surgery

Surgical group

ACTIVE COMPARATOR

In this group, the patients with clinically complete response will undergo surgical treatment (LAR with anal preservation or APR)

Procedure: Surgery

Interventions

Surgery PROCEDURE

Surgery procedures include LAR+ anal preservation or APR

Surgical group; Watch and wait group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Jin-Tung LIANG

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jin-Tung LIANG, MD

  National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Jin-Tung LIANG, MD

CONTACT

+886-972654554; jintung@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 28, 2023
• Study Start: April 19, 2023
• Primary Completion: April 19, 2026
• Study Completion (Estimated): October 19, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

TW (1)