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Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00726622
First received: July 31, 2008
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

RATIONALE: Laparoscopic-assisted resection is a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether laparoscopic-assisted resection is more effective than open resection in treating patients with rectal cancer.

PURPOSE: This randomized phase III trial is studying laparoscopic-assisted resection to see how well it works compared with open resection in treating patients with stage IIA, stage IIIA, or stage IIIB rectal cancer.


Condition Intervention Phase
Colorectal Cancer
 Procedure: therapeutic conventional surgery
Procedure: therapeutic laparoscopic surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Circumferential margin > 1 mm [ Designated as safety issue: No ]
  • Negative distal resected margin [ Designated as safety issue: No ]
  • Completeness of total mesorectal excision (complete or nearly complete) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-related benefit [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Local pelvic recurrence rates [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Sexual function and bowel function [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: August 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo open laparotomy and rectal resection.
 Procedure: therapeutic conventional surgery
Patients undergo open laparotomy and rectal resection.
Experimental: Arm II
Patients undergo laparoscopic-assisted rectal resection.
 Procedure: therapeutic laparoscopic surgery
Patients undergo laparoscopic-assisted rectal resection.

Detailed Description:

OBJECTIVES:

Primary

  • To test the hypothesis that laparoscopic-assisted resection is not inferior to open resection, based on a composite primary endpoint of oncologic factors that are indicative of a safe and feasible surgical resection, in patients with stage IIA, IIIA, or IIIB rectal cancer.

Secondary

  • To compare the patient-related benefit of laparoscopic-assisted resection vs open resection, in terms of blood loss, length of stay, and utilization of pain medication.
  • To compare the disease-free survival and local pelvic recurrence at 2 years.
  • To compare the quality of life, sexual function, and bowel and stoma function.

OUTLINE: This is a multicenter study. Patients are stratified according to site of primary tumor (high vs middle vs low rectum), registering surgeon, and planned operative procedure (low anterior resection vs abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo open laparotomy and rectal resection.
  • Arm II: Patients undergo laparoscopic-assisted rectal resection. Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), the Linear Analog Self-Assessment (LASA), the Stoma Quality of Life Scale (SQOLS), and the Mayo Bowel Function Questionnaire (MBFQ).

After completion of study treatment, patients are followed periodically for up to 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the rectum (≤ 12 cm from the anal verge)

    • T3, N0, M0 or T1-3, N1-2, M0 disease by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound

      • No T4 disease

  • Must have completed neoadjuvant fluorouracil-based chemotherapy and/or radiotherapy within the past 4 weeks

    • Capecitabine may have been substituted for fluorouracil

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Body mass index ≤ 34
  • Negative pregnancy test
  • No evidence of conditions (e.g., multiple prior major laparotomies or severe adhesions) that would preclude use of a laparoscopic approach
  • No systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude surgery
  • No other severe incapacitating disease (i.e., ASA IV [severe systemic disease that is a constant threat to life] or ASA V [moribund and is not expected to survive without the operation])
  • No other invasive pelvic malignancy (cervical, uterine, or rectal) within the past 5 years
  • No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726622

  Show 37 Study Locations
Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)
Investigators
Study Chair: James W. Fleshman, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: David M. Ota, American College of Surgeons Oncology Group
ClinicalTrials.gov Identifier: NCT00726622     History of Changes
Other Study ID Numbers: CDR0000601816, ACOSOG-Z6051
Study First Received: July 31, 2008
Last Updated: February 7, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIA rectal cancer
stage IIIA rectal cancer
stage IIIB rectal cancer
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on May 19, 2013