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| Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 23, 2012 |
| Title of trial/grant title | Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer |
| Current status of trial | Recruiting |
| Sponsors and collaborators | American College of Surgeons National Cancer Institute (NCI) |
| Information provided by | National Cancer Institute (NCI) |
| ClinicalTrials.gov identifier | NCT00726622 |
| Purpose | RATIONALE: Laparoscopic-assisted resection is a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether laparoscopic-assisted resection is more effective than open resection in treating patients with rectal cancer. PURPOSE: This randomized phase III trial is studying laparoscopic-assisted resection to see how well it works compared with open resection in treating patients with stage IIA, stage IIIA, or stage IIIB rectal cancer. |
| Condition(s) | Colorectal Cancer |
| Intervention(s) | Procedure: therapeutic conventional surgery Procedure: therapeutic laparoscopic surgery |
| Phase | Phase III |
| Study type and design | Allocation: Randomized, Primary Purpose: Treatment |
| Official title | A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer |
| Further study details | OBJECTIVES: Primary - To test the hypothesis that laparoscopic-assisted resection is not inferior to open resection, based on a composite primary endpoint of oncologic factors that are indicative of a safe and feasible surgical resection, in patients with stage IIA, IIIA, or IIIB rectal cancer. Secondary - To compare the patient-related benefit of laparoscopic-assisted resection vs open resection, in terms of blood loss, length of stay, and utilization of pain medication. - To compare the disease-free survival and local pelvic recurrence at 2 years. - To compare the quality of life, sexual function, and bowel and stoma function. OUTLINE: This is a multicenter study. Patients are stratified according to site of primary tumor (high vs middle vs low rectum), registering surgeon, and planned operative procedure (low anterior resection vs abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo open laparotomy and rectal resection. - Arm II: Patients undergo laparoscopic-assisted rectal resection. Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), the Linear Analog Self-Assessment (LASA), the Stoma Quality of Life Scale (SQOLS), and the Mayo Bowel Function Questionnaire (MBFQ). After completion of study treatment, patients are followed periodically for up to 5 years. |
| Primary outcome | Circumferential margin > 1 mm No Distal resected margin > 2 cm (or > 1 cm with clear frozen section in the low rectum) No Completeness of total mesorectal excision No |
| Secondary outcome | Patient-related benefit No Disease-free survival No Local pelvic recurrence rates No Overall survival No Quality of life No Sexual function and bowel function No |
| Study start | August 2008 |
| Minimum age | 18 Years |
| Maximum age | N/A |
| Gender | Both |
| Eligibility criteria | DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the rectum (⿤ 12 cm from the anal verge) - T3, N0, M0 or T1-3, N1-2, M0 disease by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound - No T4 disease - Must have completed neoadjuvant fluorouracil-based chemotherapy and/or radiotherapy within the past 4 weeks - Capecitabine may have been substituted for fluorouracil PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Body mass index ⿤ 34 - Negative pregnancy test - No evidence of conditions (e.g., multiple prior major laparotomies or severe adhesions) that would preclude use of a laparoscopic approach - No systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude surgery - No other severe incapacitating disease (i.e., ASA IV [severe systemic disease that is a constant threat to life] or ASA V [moribund and is not expected to survive without the operation]) - No other invasive pelvic malignancy (cervical, uterine, or rectal) within the past 5 years - No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
| Study chairs or principal investigators | James W. Fleshman, MD, Study Chair, Washington University Siteman Cancer Center |
| Locations | Arizona, United States Mayo Clinic Scottsdale Scottsdale Arizona 85259-5499 Status: Recruiting Contact: Clinical Trials Office - All Mayo Clinic Locations tel: 507-538-7623 California, United States Cancer Care Center at John Muir Health - Concord Campus Concord California 94524-4110 Status: Recruiting Contact: Clinical Trials Office - Cancer Care Center at John Muir Healt tel: 925-674-2580 California, United States Rebecca and John Moores UCSD Cancer Center La Jolla California 92093-0658 Status: Recruiting Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer tel: 858-822-5354 cancercto@ucsd.edu California, United States Kaiser Permanente Medical Center - Los Angeles Los Angeles California 90027 Status: Recruiting Contact: Maher A. Abbas tel: 323-667-4011 California, United States California Pacific Medical Center - California Campus San Francisco California 94118 Status: Recruiting Contact: David H. Irwin, MD tel: 510-204-1591 California, United States John Muir/Mt. Diablo Comprehensive Cancer Center Walnut Creek California 94598 Status: Recruiting Contact: Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Ca tel: 925-941-4246 Florida, United States Cleveland Clinic Florida - Weston Weston Florida 33331 Status: Recruiting Contact: Clinical Trials Office - Cleveland Clinic Florida - Weston tel: 954-659-5705 Georgia, United States John B. Amos Cancer Center Columbus Georgia 31904 Status: Recruiting Contact: Clinical Trials Office - John B. Amos Cancer Center tel: 706-660-6404 Illinois, United States Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois 60611-3013 Status: Recruiting Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer tel: 312-695-1301 cancer@northwestern.edu Illinois, United States Rush University Medical Center Chicago Illinois 60612 Status: Recruiting Contact: Clinical Trials Office - Rush University Medical Center tel: 312-942-5498 clinical_trials@rush.edu Illinois, United States University of Illinois Cancer Center Chicago Illinois 60612-7243 Status: Recruiting Contact: Clinical Trial Office - University of Illinois Cancer Center tel: 312-355-3046 Illinois, United States University of Chicago Cancer Research Center Chicago Illinois 60637-1470 Status: Recruiting Contact: Clinical Trials Office - University of Chicago Cancer Research tel: 773-834-7424 Illinois, United States Evanston Hospital Evanston Illinois 60201-1781 Status: Recruiting Contact: Clinical Trials Office - Evanston Hospital tel: 847-570-1381 Illinois, United States Advocate Lutheran General Cancer Care Center Park Ridge Illinois 60068-1174 Status: Recruiting Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care tel: 847-384-3621 Indiana, United States Clarian North Medical Center Carmel Indiana 46032 Status: Recruiting Contact: Virgilio George tel: Not Available Indiana, United States Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana 46202-5289 Status: Recruiting Contact: Clinical Trials Office - Indiana University Cancer Center tel: 317-274-2552 Indiana, United States Veterans Affairs Medical Center - Indianapolis Indianapolis Indiana 46202 Status: Recruiting Contact: Virgilio George tel: 317-554-0000 Indiana, United States William N. Wishard Memorial Hospital Indianapolis Indiana 46202 Status: Recruiting Contact: Virgilio George tel: 317-639-6671 Indiana, United States Kendrick Regional Center for Colon and Rectal Care - Mooresville Mooresville Indiana 46158 Status: Recruiting Contact: Dipen C. Maun tel: 317-834-2020 Iowa, United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa 52242-1002 Status: Recruiting Contact: Cancer Information Service tel: 800-237-1225 Louisiana, United States Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana 70121 Status: Recruiting Contact: David A. Margolin tel: 504-842-4360 Maryland, United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21231-2410 Status: Recruiting Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce tel: 410-955-8804 jhcccro@jhmi.edu Massachusetts, United States Lahey Clinic Medical Center - Burlington Burlington Massachusetts 01805 Status: Recruiting Contact: Clinical Trials Office - Lahey Clinic Medical Center - Burling tel: 781-744-8027 Michigan, United States Blodgett Hospital at Spectrum Health Grand Rapids Michigan 49506 Status: Recruiting Contact: Rebecca E. Hoedema tel: 616-774-7444 Minnesota, United States Mayo Clinic Cancer Center Rochester Minnesota 55905 Status: Recruiting Contact: Clinical Trials Office - All Mayo Clinic Locations tel: 507-538-7623 Missouri, United States Boone Hospital Center Columbia Missouri 65201 Status: Recruiting Contact: Walter R. Peters, Jr. tel: 573-815-8000 Missouri, United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri 63110 Status: Recruiting Contact: James W. Fleshman tel: 314-747-7222 New York, United States Memorial Sloan-Kettering Cancer Center New York New York 10065 Status: Recruiting Contact: Martin R. Weiser tel: 212-639-8895 New York, United States St. Luke's - Roosevelt Hospital Center - St.Luke's Division New York New York 10025 Status: Recruiting Contact: Richard L. Whelan tel: 212-523-4000 New York, United States Stony Brook University Cancer Center Stony Brook New York 11794-9446 Status: Recruiting Contact: Clinical Trials Office - Stony Brook University Cancer Center tel: 800-862-2215 New York, United States SUNY Upstate Medical University Hospital Syracuse New York 13210 Status: Recruiting Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi tel: 315-464-5476 Ohio, United States Case Comprehensive Cancer Center Cleveland Ohio 44106-5065 Status: Recruiting Contact: Clinical Trials Office - Case Comprehensive Cancer Center tel: 800-641-2422 Ohio, United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195 Status: Recruiting Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente tel: 866-223-8100 Oklahoma, United States INTEGRIS Cancer Institute of Oklahoma - Proton Campus Oklahoma City Oklahoma 73142 Status: Recruiting Contact: Chris M. Davis, MD tel: 405-949-3870 Oregon, United States Providence Cancer Center at Providence Portland Medical Center Portland Oregon 97213-2967 Status: Recruiting Contact: Clinical Trials Office - Providence Cancer Center at Providenc tel: 503-215-6412 Pennsylvania, United States Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania 15224-1791 Status: Recruiting Contact: James T. McCormick tel: 412-578-5000 Pennsylvania, United States UPMC Cancer Centers Pittsburgh Pennsylvania 15232 Status: Recruiting Contact: Clinical Trials Office - UPMC Cancer Centers tel: 412-647-8073 Pennsylvania, United States Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania 19096 Status: Recruiting Contact: Ned Z. Carp, MD tel: 610-642-1908 Tennessee, United States Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232-6838 Status: Recruiting Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center tel: 800-811-8480 Wisconsin, United States University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin 53792-6164 Status: Recruiting Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo tel: 608-262-5223 British Columbia, Canada St. Paul's Hospital at Providence Health Care - Vancouver Vancouver British Columbia V6Z 1Y6 Status: Recruiting Contact: P. T. Phang tel: 604-806-9090 Ontario, Canada St. Joseph's Hospital - Charlton Campus Hamilton Ontario L8N 4A6 Status: Recruiting Contact: Mehran Anvari tel: 905-522-4941 |
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database |
| Study ID numbers | CDR0000601816; ACOSOG-Z6051 |
| Last updated | April 7, 2011 |
| Record first received | July 31, 2008 |
| ClinicalTrials.gov identifier | NCT00726622 |
| Download date | Information obtained from ClinicalTrials.gov on February 23, 2012 |
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