Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over NCI NCCTG-934653 CAN-NCIC-CO12, CLB-9396, E-7293, NSABP-CI64, RTOG-9415, SWOG-9411, INT-0146, NCT00002575, CO11

Objectives

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

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics
• No prohibitive scars/adhesions from prior abdominal surgery

Other:

• No concurrent investigational treatments or invasive diagnostic procedures within 30 days after surgery

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

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

Expected Enrollment

A total of 810 patients will be accrued for this study within 3 years.

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.

• Arm I: 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.



• Arm II: 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.

Larson DW, Marcello PW, Larach SW, et al.: Surgeon volume does not predict outcomes in the setting of technical credentialing: results from a randomized trial in colon cancer. Ann Surg 248 (5): 746-50, 2008.[PUBMED Abstract]

Clinical Outcomes of Surgical Therapy Study Group.: A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 350 (20): 2050-9, 2004.[PUBMED Abstract]

Weeks JC, Nelson H, Gelber S, et al.: Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA 287 (3): 321-8, 2002.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Heidi Nelson, MD, Protocol chair		Ph: 507-284-3329

Southwest Oncology Group

Robert Beart, MD, Protocol chair		Ph: 323-865-3690; 800-865-0102 Email: rbeart@usc.edu

Eastern Cooperative Oncology Group

Mark Talamonti, MD, Protocol chair		Ph: 312-695-2534

Radiation Therapy Oncology Group

John Skibber, MD, Protocol chair		Ph: 713-792-5165; 800-392-1611

Cancer and Leukemia Group B

Jane Weeks, MD, Protocol chair		Ph: 617-632-2509; 866-790-4500

NCIC-Clinical Trials Group

Hartley Stern, MD, Protocol chair		Ph: 613-737-7700 ext. 70269; 888-627-5346

National Surgical Adjuvant Breast and Bowel Project

Thomas Julian, MD, Protocol chair		Ph: 412-359-8720; 866-680-0004 Email: tjulian@WPAHS.org

Registry Information
Official Title		A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER
Trial Start Date		1994-08-15
Registered in ClinicalTrials.gov		NCT00002575
Date Submitted to PDQ		1994-08-15
Information Last Verified		2002-10-18
NCI Grant/Contract Number		CA65157, CA25224