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Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00002575
First received: November 1, 1999
Last updated: July 15, 2016
Last verified: July 2016
  Purpose

RATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    • Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy.
    • Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients.
    • Compare the differences in costs and cost effectiveness between these treatments in this patient population.
    • Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)

  • Overall survival [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: At 30 days ] [ Designated as safety issue: No ]
  • Costs and cost effectiveness between these treatments in this patient population [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Compare the differences in quality of life of patients treated with these regimens [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]

Enrollment: 810
Study Start Date: August 1994
Study Completion Date: November 2009
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional surgery

Patients undergo open laparotomy and colectomy. A standard incision is made through the abdominal wall and the abdominal cavity is explored. A right or left colectomy or a sigmoid resection is performed.

Patients may be entered on adjuvant chemotherapy trials after surgery provided the subsequent trial does not include radiotherapy and allows entry of patients from both arms.

Quality of life is assessed at baseline and on days 2 and 14 after surgery, at 2 months, and then at 18 months. (closed as of 4/30/99)

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 3 years.

Procedure: conventional surgery
Experimental: Laparoscopic-assisted colectomy

Patients undergo a laparoscopic-assisted colectomy. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with CO2 to allow access and visualization. The abdominal cavity is explored. If advanced local disease is identified, a celiotomy and colectomy are performed. Otherwise, a right or left colectomy or sigmoid resection is performed using laparoscopic-assisted techniques.

Patients may be entered on adjuvant chemotherapy trials after surgery provided the subsequent trial does not include radiotherapy and allows entry of patients from both arms.

Quality of life is assessed at baseline and on days 2 and 14 after surgery, at 2 months, and then at 18 months. (closed as of 4/30/99)

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 3 years.

Procedure: laparoscopic surgery

Detailed Description:

OBJECTIVES:

  • Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy.
  • Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients.
  • Compare the differences in costs and cost effectiveness between these treatments in this patient population.
  • Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and American Society of Anesthesiologists disease classification (I and II vs III). Patients are randomized to one of two treatment arms.

The extent of colon resection is identical for both arms.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Clinical diagnosis of primary adenocarcinoma

    • Involving a single colon segment:

      • Right colon from the ileocecal valve up to and including the hepatic flexure
      • Left colon from the splenic flexure to the junction of the sigmoid and descending colon
      • Sigmoid colon between the descending colon and the rectum (at least 15 cm from the dentate)
  • Diagnosis based on physical exam plus either a proctosigmoidoscopy and barium enema or a colonoscopy
  • No advanced local disease that renders laparoscopic resection impossible
  • No acutely obstructed or perforated colon cancer requiring urgent surgery
  • No transverse colon cancer (i.e., between distal hepatic flexure and proximal splenic flexure)
  • No stage IV disease
  • No rectal cancer (i.e., below the peritoneal reflection, lower edge of tumor less than 15 cm from dentate)
  • No American Society of Anesthesiologists IV/V disease classification
  • No associated gastrointestinal diseases (i.e., Crohn's, chronic ulcerative colitis, or familial polyposis) that require additional extensive operative evaluation or intervention

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Other:

  • No other prior or concurrent malignancy within the past 5 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Surgery:

  • No prohibitive scars/adhesions from prior abdominal surgery

Other:

  • No concurrent investigational treatments or invasive diagnostic procedures within 30 days after surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002575

  Show 158 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Investigators
Study Chair: Heidi Nelson, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00002575     History of Changes
Other Study ID Numbers: NCCTG-934653  NCI-2012-02234  CAN-NCIC-CO12  CDR0000063648 
Study First Received: November 1, 1999
Last Updated: July 15, 2016
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I colon cancer
stage II colon cancer
stage III colon cancer
adenocarcinoma of the colon

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

ClinicalTrials.gov processed this record on December 09, 2016