Outcome of Resection for Colorectal Cancer

NCT03837782 | Enrolling By Invitation DMC

• 1 other identifier: LRLCC
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

There are limited data from retrospective studies regarding whether short-term and long-term outcomes after laparoscopic or robot-assisted radical colectomy (minimally invasive surgery) are equivalent to those after open abdominal radical colectomy (open surgery) among patients with early and medium-stage colorectal cancer. This trial is a multicenter,prospective, randomized trial evaluating short-term and survival outcomes concerning minimally invasive surgery and open surgery for colorectal cancer.

Conditions

Laparoscopy

Keywords

laparoscopy,laparotomy,colorectal cancer

Outcome Measures

Primary Outcomes (3)

• complications

  complications includes intraoperative and postoperative complications, such as huge blood loss, anastomotic fistula, abdominal infection and septic shock.

  through hospital stay, an average of two weeks

• disease free survival

  Disease-free survival (DFS) was defined as the interval between the date of surgical resection and diagnosis of recurrence or the most recent follow-up date.

  From date of randomization until the date of first documented progression, assessed up to 70 months

• overall survival

  Overall survival (OS) was measured from the date of hepatectomy to death with or without HCC recurrence or the end of this study period.

  From date of randomization until the date of death from any cause, assessed up to 70 months.

Study Arms (2)

minimally invasive surgery

EXPERIMENTAL

Patients were randomized to undergo minimally invasive radical resection (endoscopic surgery or robotic assisted surgery). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability).

Procedure: minimally invasive surgery

open surgery

NO INTERVENTION

Patients were randomized to undergo open radical resection (laparotomy). Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. Patients were eligible if they had colorectal adenocarcinoma; had a disease stage of I (T1,T2), IIABC (T3-T4ab) or IIIABC (TanyN1-2) according to the staging system of NCCN; and had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher values indicating greater disability). Exclusion criteria included a history of abdominal or pelvic radiotherapy, or evidence of metastatic disease on positron-emission tomography-computed tomography, magnetic resonance imaging, or computed tomography.

Interventions

minimally invasive surgery PROCEDURE

Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. No individual surgeons performed only the open approach or only the minimally invasive approach. The committee members reviewed the patients' outcomes and the videos to ensure the adequacy of the surgeon's technique.

minimally invasive surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (i) tumor without distant metastasis; (ii) classified as stage I, II or III by TNM staging system; (iii) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; (iv) a minimum of 12 lymph nodes resected to accurately identify stage; (v) solitary malignant lesion after thorough colonoscopy; (vi) complete resection (R0) with no positive nodes left behind; (vii) histological diagnosis of adenocarcinoma.

You may not qualify if:

• (i) \<18 years or \>90 years; (ii) serious concurrent illness; (iii) clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT); (iv) familial adenomatous polyposis syndrome (FAP), hereditary non-polyposis colorectal cancer (HNPCC) and other hereditary CRC; (v) postoperative pathological close, indeterminate, or positive margins; (vi) circumferential resection margin \< 1mm in rectal cancer; (vii) short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Qilu Hospital of Shandong University: collaborator
• Zhejiang University: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Zhengzhou University: collaborator
• Peking Union Medical College: collaborator
• Sun Yat-sen University: collaborator
• Fudan University: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator
• Massachusetts General Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• M.D. Anderson Cancer Center: collaborator
• University of California, Los Angeles: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

Minimally Invasive Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Dalu M Kong, M.D.

  Tianjin Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients were randomized to be distributed to any group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter, randomized trial

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 12, 2019
• Study Start: February 15, 2019
• Primary Completion: November 1, 2019
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2019

Record last verified: 2019-01

Locations

CN (1)