Trial record 1 of 1 for:    Z6051
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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:
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

July 31, 2008
February 7, 2013
August 2008
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00726622 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer
A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Colorectal Cancer
  • Procedure: therapeutic conventional surgery
    Patients undergo open laparotomy and rectal resection.
  • Procedure: therapeutic laparoscopic surgery
    Patients undergo laparoscopic-assisted rectal resection.
  • Active Comparator: Arm I
    Patients undergo open laparotomy and rectal resection.
    Intervention: Procedure: therapeutic conventional surgery
  • Experimental: Arm II
    Patients undergo laparoscopic-assisted rectal resection.
    Intervention: Procedure: therapeutic laparoscopic surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States,   Canada
 
NCT00726622
CDR0000601816, ACOSOG-Z6051
Not Provided
David M. Ota, American College of Surgeons Oncology Group
American College of Surgeons
National Cancer Institute (NCI)
Study Chair: James W. Fleshman, MD Washington University Siteman Cancer Center
National Cancer Institute (NCI)
February 2013

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