Comparison Between Tailored Surgery Versus Total Mesorectal Excision in ycT2-3N0M0

NCT05164315 | Terminated

• 1 other identifier: B-2107-697-002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to show that tailored treatment based on local excision can expand the target of non-radical treatment in ycT2-3N0M0 patients after neoadjuvant chemoradiotherapy for low rectal cancer and that the oncologic safety is not inferior to that of total mesorectal excision.

Conditions

Rectal Cancer, Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  The percentage of people in a study or treatment group who are alive five years after their diagnosis or the date of randomization

  5 years

Secondary Outcomes (5)

• Immediate postoperative index

  postoperative 30 days

• Oncologic outcomes

  5 years

• Quality of Life evaluation

  Conduct a survey before surgery and every year after surgery until the 3rd year

• Sexual/urination function evaluation

  Conduct a survey before surgery and every year after surgery until the 3rd year

• defecation function

  Conduct before surgery and at 1, 2, and 3 years after surgery, (at 1, 2, and 3 years after stoma restoration).

Study Arms (2)

Tailored surgery

EXPERIMENTAL

Arm 1 will receive tailored surgery. If there are no cancer cells or the margin is negative in the local excision/biopsy during surgery, the operation will be terminated. And if the final pathology result is T2-4, or cancer cells and margin are positive in the frozen section during surgery, or the result of digital rectal examination and visual examination using anoretractor under general anesthesia is not suitable for local excision (visible and palpable tumor nodules), a total mesorectal excision will be performed.

Procedure: Tailored surgery

Total mesorectal excision (TME)

ACTIVE COMPARATOR

Arm 2 will receive TME. Surgery including high ligation of the inferior mesenteric artery and total mesorectal excision will be performed under the lithotomy position. After pelvic dissection, double-stapled anastomosis or transanal anastomosis will be performed, followed by diverting stoma. Abdominoperineal resection with permanent stoma is included.

Procedure: Total mesorectal excision (TME)

Interventions

Tailored surgery PROCEDURE

Procedure: Tailored surgery based on intraoperative local excision/biopsy

Tailored surgery

Total mesorectal excision (TME) PROCEDURE

Procedure: Total mesorectal excision for all allocated patients

Total mesorectal excision (TME)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of adenocarcinoma of the rectum (AV≤5cm)
• Clinical ycT2-3N0 based on MRI after neoadjuvant chemoradiotherapy (including long/short-course chemoradiotherapy, total neoadjuvant therapy etc…)
• No evidence of distant metastases
• No prior pelvic radiation therapy
• No prior chemotherapy or surgery for rectal cancer
• Age 18 to 80 years
• No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)
• Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. A woman of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.
• Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Patients who do not read or understand Korean are eligible and may be consented according to institutional and federal regulations.
• Hemoglobin ≥ 10 g/dl (after correction for simple iron deficiency anemia), White blood cells ≥ 4,000/mm3, Platelets ≥ 100,000/mm3, Creatinine ≤ 1.5 mg/dl
• No significant dysfunction in the heart or lungs: When it is judged that the risk related to surgery due to functional impairment is not high during consultation treatment

You may not qualify if:

• Metastasis to the liver, lung, brain, bone, abdominal aortic lymph node, subclavian lymph node, inguinal lymph node, etc. at the time of evaluation before treatment
• Patients with a history of a prior malignancy
• Patients with serious heart disease and heart failure, severe lung disease or pulmonary insufficiency, active bacterial infection requiring parenteral antibiotic administration and/or other serious medical conditions
• Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
• When it is legally impossible to participate in a clinical trial
• Patients who are pregnant or lactating
• When existing diseases and disorders are expected to affect the quality of life evaluation after surgery

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 20, 2021
• Study Start: January 3, 2022
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

KR (1)