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Outcome of Resection for Colorectal Cancer (LRLCC)

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ClinicalTrials.gov Identifier: NCT03837782
Recruitment Status : Enrolling by invitation
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
Qilu Hospital of Shandong University
Zhejiang University
Beijing Cancer Hospital
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
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  ICMJE January 31, 2019
First Posted Date  ICMJE February 12, 2019
Last Update Posted Date February 12, 2019
Estimated Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcome of Resection for Colorectal Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Laparoscopy
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: February 9, 2019)
1300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03837782
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Tianjin Medical University Cancer Institute and Hospital
Study Sponsor  ICMJE Tianjin Medical University Cancer Institute and Hospital
Collaborators  ICMJE
  • Qilu Hospital of Shandong University
  • Zhejiang University
  • Beijing Cancer Hospital
  • 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
  • M.D. Anderson Cancer Center
  • University of California, Los Angeles
  • University of Pennsylvania
Investigators  ICMJE
Study Director: Dalu M Kong, M.D. Tianjin Medical University
PRS Account Tianjin Medical University Cancer Institute and Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP