Outcome of Resection for Colorectal Cancer (LRLCC)

• ClinicalTrials.gov Identifier: NCT03837782
• Recruitment Status: Enrolling by invitation
• First Posted: February 12, 2019
• Last Update Posted: February 12, 2019
• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Qilu Hospital of Shandong University; Zhejiang University; Peking University Cancer Hospital & Institute; Zhengzhou University; Peking Union Medical College; Sun Yat-sen University; Fudan University; Shanghai Jiao Tong University School of Medicine; Massachusetts General Hospital; Harvard Medical School (HMS and HSDM); M.D. Anderson Cancer Center; University of California, Los Angeles; University of Pennsylvania
• Information provided by (Responsible Party): Tianjin Medical University Cancer Institute and Hospital

Tracking Information

• First Submitted Date: January 31, 2019
• First Posted Date: February 12, 2019
• Last Update Posted Date: February 12, 2019
• Estimated Study Start Date: February 15, 2019
• Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2019)

• complications [ Time Frame: through hospital stay, an average of two weeks ]
  complications includes intraoperative and postoperative complications, such as huge blood loss, anastomotic fistula, abdominal infection and septic shock.
• disease free survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 70 months ]
  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.
• overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 70 months. ]
  Overall survival (OS) was measured from the date of hepatectomy to death with or without HCC recurrence or the end of this study period.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Outcome of Resection for Colorectal Cancer
• Official Title: Minimally Invasive Versus Abdominal Radical Resection for Colorectal Cancer

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.

Detailed Description

Radical colectomy and proctectomy with regional lymphadenectomy remain the standard recommendation for patients with early and medium-stage colorectal cancer. Current guidelines from the National Comprehensive Cancer Network indicate that either laparotomy (open surgery) or laparoscopy (minimally invasive surgery performed with either conventional or robotic techniques) is an acceptable approach to radical resection in patients with early- and medium stage (I to III) colorectal cancer. These recommendations have led to widespread use of a minimally invasive approach for radical resection, although there is a paucity of adequately powered, prospective, randomized trials evaluating short term and survival outcomes.

Retrospective studies involving patients with early and medium-stage colorectal cancer have shown that laparoscopic resection is associated with less intraoperative blood loss, a shorter length of hospital stay, and a lower risk of postoperative complications than open abdominal radical resection. Similarly, the minimally invasive approach has not been associated with lower 5-year rates of disease-free survival or overall survival than the open approach. In addition, retrospective studies have shown that recurrence rates and survival rates do not differ significantly between the two approaches.

The investigators hypothesized that minimally invasive surgery was not inferior or superior to open radical resection in terms of short-term and long-term outcome. In the present trial, the Laparoscopic Resection and Laparotomy for Colorectal Cancer (LRLCC) Trial, the investigators tested this hypothesis by prospectively assigning patients to minimally invasive (conventional laparoscopic or robotic) or open abdominal radical surgery and comparing the short-term outcome, the rate of recurrence, and the overall survival rate between the two groups.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

multicenter, randomized trial

Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Patients were randomized to be distributed to any group.

Primary Purpose: Treatment

• Condition: Laparoscopy

Intervention

Procedure: minimally invasive surgery

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.

Study Arms

• Experimental: minimally invasive surgery

  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).

  Intervention: Procedure: minimally invasive surgery
• No Intervention: open surgery

  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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: February 9, 2019): 1300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03837782
• Other Study ID Numbers: LRLCC
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Tianjin Medical University Cancer Institute and Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Study Director: Dalu M Kong, M.D.; Tianjin Medical University

• PRS Account: Tianjin Medical University Cancer Institute and Hospital
• Verification Date: January 2019