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NCI HIGH PRIORITY CLINICAL TRIAL --- Phase III Randomized Study of Laparoscopic-Assisted Colectomy Versus Open Colectomy for Colon Cancer
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
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Protocol IDs
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Phase III
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Treatment
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Closed
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18 and over
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NCI
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NCCTG-934653 CAN-NCIC-CO12, CLB-9396, E-7293, NSABP-CI64, RTOG-9415, SWOG-9411, INT-0146, NCT00002575, CO11
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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)
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: Chemotherapy: Endocrine therapy: Radiotherapy: 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: Performance status: Hematopoietic: Hepatic: Renal: 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 810A 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. Published ResultsLarson 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 | | | |
Southwest Oncology Group | | | Robert Beart, MD, Protocol chair | | | |
Eastern Cooperative Oncology Group | | | Mark Talamonti, MD, Protocol chair | | | |
Radiation Therapy Oncology Group | | | John Skibber, MD, Protocol chair | | Ph: 713-792-5165; 800-392-1611 |
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Cancer and Leukemia Group B | | | Jane Weeks, MD, Protocol chair | | Ph: 617-632-2509; 866-790-4500 |
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NCIC-Clinical Trials Group | | | Hartley Stern, MD, Protocol chair | | Ph: 613-737-7700 ext. 70269; 888-627-5346 |
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National Surgical Adjuvant Breast and Bowel Project | | | Thomas Julian, MD, Protocol chair | | | |
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 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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