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



Status:Completed
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 1994
End Date:November 2009

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A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER

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.

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.

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
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Houston, Texas 77025
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
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Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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33 Villa Road, Suite 400
Greenville, South Carolina 29615
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CCOP - Greenville Cancer care in the last decade has made many advances. Most of...
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701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
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529 West Markham Street
Little Rock, Arkansas 72205
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300 Community Drive
Manhasset, New York 11030
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4300 Alton Road
Miami Beach, Florida 33140
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Norfolk, Virginia 23507
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4502 Medical Drive
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34800 Bob Wilson Dr,
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1200 S Cedar Crest Blvd
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1335 Dublin Road, Suite 124A
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