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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02234 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CAN-NCIC-CO12 | |||
| CDR0000063648 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NCIC Clinical Trials Group | NETWORK |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional surgery | Experimental | 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. |
|
| Laparoscopic-assisted colectomy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional surgery | Procedure |
| ||
| laparoscopic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival |
| Up to 8 years |
| Overall survival | Up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Up to 8 years | |
| Mortality | At 30 days | |
| Costs and cost effectiveness between these treatments in this patient population |
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DISEASE CHARACTERISTICS:
Clinical diagnosis of primary adenocarcinoma
Involving a single colon segment:
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:
Other:
PRIOR CONCURRENT THERAPY:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Nelson, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital System | Huntsville | Alabama | 35801-4470 | United States | ||
| MBCCOP - Gulf Coast |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21452066 | Result | Stucky CC, Pockaj BA, Novotny PJ, Sloan JA, Sargent DJ, O'Connell MJ, Beart RW, Skibber JM, Nelson H, Weeks JC. Long-term follow-up and individual item analysis of quality of life assessments related to laparoscopic-assisted colectomy in the COST trial 93-46-53 (INT 0146). Ann Surg Oncol. 2011 Sep;18(9):2422-31. doi: 10.1245/s10434-011-1650-2. Epub 2011 Mar 31. | |
| 18948801 |
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|
| Up to 8 years |
| Compare the differences in quality of life of patients treated with these regimens | Up to 8 years |
| Mobile |
| Alabama |
| 36688 |
| United States |
| CCOP - Greater Phoenix | Phoenix | Arizona | 85006-2726 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| St. Mary's Hospital | Rogers | Arkansas | 72756 | United States |
| Cancer Center and Beckman Research Institute, City of Hope | Duarte | California | 91010-3000 | United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| University of California San Diego Cancer Center | La Jolla | California | 92093-0658 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Saint Mary Medical Center - Long Beach | Long Beach | California | 90813-0887 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States |
| Naval Medical Center - Oakland | Oakland | California | 94627-5000 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| Veterans Affairs Satellite Clinic - Sacramento | Sacramento | California | 95820 | United States |
| Naval Medical Center - San Diego | San Diego | California | 92134-3202 | United States |
| Veterans Affairs Medical Center - San Francisco | San Francisco | California | 94121 | United States |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | 95403 | United States |
| Kaiser Permanente Medical Center - Vallejo | Vallejo | California | 94589 | United States |
| University of Colorado Cancer Center | Denver | Colorado | 80010 | United States |
| CCOP - Colorado Cancer Research Program, Inc. | Denver | Colorado | 80209-5031 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102-5037 | United States |
| CCOP - Christiana Care Health Services | Wilmington | Delaware | 19899 | United States |
| Baptist Regional Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | United States |
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| MD Anderson Cancer Center Orlando | Orlando | Florida | 32806 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| CCOP - Atlanta Regional | Atlanta | Georgia | 30342-1701 | United States |
| Medical College of Georgia Comprehensive Cancer Center | Augusta | Georgia | 30912-4000 | United States |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | 30033 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | 60611 | United States |
| MBCCOP-Cook County Hospital | Chicago | Illinois | 60612 | United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Illinois Masonic Medical Center | Chicago | Illinois | 60657 | United States |
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| West Suburban Hospital Medical Center | Oak Park | Illinois | 60302 | United States |
| Rockford Clinic | Rockford | Illinois | 61103 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Regional Cancer Center | Indianapolis | Indiana | 46219 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309-1016 | United States |
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242-1009 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Lucille Parker Markey Cancer Center, University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Norton Healthcare System | Louisville | Kentucky | 40202-5070 | United States |
| Baptist Hospital East - Louisville | Louisville | Kentucky | 40207 | United States |
| Louisiana State University Medical Center - New Orleans | New Orleans | Louisiana | 70112 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | 70112 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | United States |
| National Naval Medical Center | Bethesda | Maryland | 20889-5000 | United States |
| Regional Cancer Therapy Center - Frederick | Frederick | Maryland | 21701 | United States |
| New England Medical Center Hospital | Boston | Massachusetts | 02111 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Lahey Clinic - Burlington | Burlington | Massachusetts | 01805 | United States |
| Berkshire Medical Center | Pittsfield | Massachusetts | 01201 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| University of Massachusetts Memorial Healthcare | Worester | Massachusetts | 01605 | United States |
| CCOP - Ann Arbor Regional | Ann Arbor | Michigan | 48106 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| Providence Hospital - Southfield | Southfield | Michigan | 48075-9975 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | 39534-2576 | United States |
| Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | 65203 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| St. Louis University School of Medicine | St Louis | Missouri | 63104 | United States |
| CCOP - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Methodist Cancer Center - Omaha | Omaha | Nebraska | 68114 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | 07018-1095 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| University of New Mexico Cancer Research & Treatment Center | Albuquerque | New Mexico | 87131 | United States |
| Albany Regional Cancer Center | Albany | New York | 12208 | United States |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Champlain Valley Physicians Hospital Medical Center | Plattsburgh | New York | 12901 | United States |
| Genesee Surgical Associates | Rochester | New York | 14607 | United States |
| Staten Island University Hospital | Staten Island | New York | 10305 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | 13217 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | 27104-4241 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Veterans Affairs Medical Center - Fargo | Fargo | North Dakota | 58102 | United States |
| CCOP - Merit Care Hospital | Fargo | North Dakota | 58122 | United States |
| Akron City Hospital | Akron | Ohio | 44309 | United States |
| Aultman Cancer Center | Canton | Ohio | 44710 | United States |
| Jewish Hospital of Cincinnati, Inc. | Cincinnati | Ohio | 45236 | United States |
| Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | 45267-0502 | United States |
| South Pointe Hospital | Cleveland | Ohio | 44122 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Kettering | Ohio | 45429 | United States |
| CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | 43623-3456 | United States |
| CCOP - Oklahoma | Tulsa | Oklahoma | 74136 | United States |
| Oregon Cancer Center | Portland | Oregon | 97201-3098 | United States |
| CCOP - Columbia River Program | Portland | Oregon | 97213 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| St. Luke's Network - Bethlehem | Bethlehem | Pennsylvania | 18015 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212-4772 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15213-3489 | United States |
| Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania | 15240 | United States |
| Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| York Hospital | York | Pennsylvania | 17315 | United States |
| Kent County Memorial Hospital | Warwick | Rhode Island | 02886 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57104 | United States |
| Baptist Regional Cancer Center - Knoxville | Knoxville | Tennessee | 37901 | United States |
| Veterans Affairs Medical Center - Memphis | Memphis | Tennessee | 38104 | United States |
| Medical Group of Texas | Dallas | Texas | 75243 | United States |
| Kelsey Seybold Clinic | Houston | Texas | 77025 | United States |
| Wilford Hall - 59th Medical Wing | Lackland Air Force Base | Texas | 78236-5300 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78284-7811 | United States |
| University of Texas Health Center at Tyler | Tyler | Texas | 75708 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| Vermont Cancer Center | Burlington | Vermont | 05401-3498 | United States |
| Virginia Oncology Associates - Newport News | Newport News | Virginia | 23606 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| Veterans Affairs Medical Center - Richmond | Richmond | Virginia | 23249 | United States |
| Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| MBCCOP - Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke | Virginia | 24014 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| Puget Sound Oncology Consortium | Seattle | Washington | 98109 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| Camden-Clark Memorial Hospital | Parkersburg | West Virginia | 26102 | United States |
| CCOP - Green Bay | Green Bay | Wisconsin | 54301 | United States |
| CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Tom Baker Cancer Center - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| St. Michael's Hospital - Toronto | Toronto | Ontario | M5B 1W8 | Canada |
| Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2L-4M1 | Canada |
| Royal Victoria Hospital - Montreal | Montreal | Quebec | H3A 1A1 | Canada |
| Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| Jewish General Hospital - Montreal | Montreal | Quebec | H3T 1E2 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| L'Hopital Laval | Ste-Foy | Quebec | G1V 4G5 | Canada |
| MBCCOP - San Juan | San Juan | 00927-5800 | Puerto Rico |
| Veterans Affairs Medical Center - San Juan | San Juan | 00927-5800 | Puerto Rico |
| Larson DW, Marcello PW, Larach SW, Wexner SD, Park A, Marks J, Senagore AJ, Thorson AG, Young-Fadok TM, Green E, Sargent DJ, Nelson H. Surgeon volume does not predict outcomes in the setting of technical credentialing: results from a randomized trial in colon cancer. Ann Surg. 2008 Nov;248(5):746-50. doi: 10.1097/SLA.0b013e31818a157d. |
| 15141043 | Result | Clinical Outcomes of Surgical Therapy Study Group; Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Ota D. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9. doi: 10.1056/NEJMoa032651. |
| 11790211 | Result | Weeks JC, Nelson H, Gelber S, Sargent D, Schroeder G; Clinical Outcomes of Surgical Therapy (COST) Study Group. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA. 2002 Jan 16;287(3):321-8. doi: 10.1001/jama.287.3.321. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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