Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer - Full Text View

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	Intervention	Phase
Colorectal Cancer	Procedure: therapeutic conventional surgery Procedure: therapeutic laparoscopic surgery	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Circumferential margin > 1 mm [ Designated as safety issue: No ]
Distal resected margin > 2 cm (or > 1 cm with clear frozen section in the low rectum) [ Designated as safety issue: No ]
Completeness of total mesorectal excision [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient-related benefit [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Local pelvic recurrence rates [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Sexual function and bowel function [ Designated as safety issue: No ]

Estimated Enrollment:	650
Study Start Date:	August 2008
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients undergo open laparotomy and rectal resection.	Procedure: therapeutic conventional surgery Patients undergo open laparotomy and rectal resection.
Arm II: Experimental Patients undergo laparoscopic-assisted rectal resection.	Procedure: therapeutic laparoscopic surgery Patients undergo laparoscopic-assisted rectal resection.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the rectum (< 12 cm from the anal verge)
- T3, N0, M0 or any T, N1, M0 disease by CT scan and pelvic MRI or transrectal ultrasound
  - No T4 disease extending to the circumferential margin of rectum or invading adjacent organs
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 0-1
Body mass index < 34
Not pregnant or nursing
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726622

Locations

United States, California
Cancer Care Center at John Muir Health - Concord Campus	Recruiting
Concord, California, United States, 94524-4110
Contact: Clinical Trials Office - Cancer Care Center at John Muir Healt 925-674-2580
John Muir/Mt. Diablo Comprehensive Cancer Center	Recruiting
Walnut Creek, California, United States, 94598
Contact: Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Ca 925-941-4246
Kaiser Permanente Medical Center - Los Angeles	Recruiting
Los Angeles, California, United States, 90027
Contact: Maher A. Abbas 323-667-4011
United States, Florida
Cleveland Clinic Florida - Weston	Recruiting
Weston, Florida, United States, 33331
Contact: Clinical Trials Office - Cleveland Clinic Florida - Weston 954-659-5705
United States, Illinois
University of Chicago Cancer Research Center	Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552
Reid Hospital & Health Care Services	Recruiting
Richmond, Indiana, United States, 47374
Contact: Daniel P. McKellar, MD 937-832-9310
St. Francis Hospital and Health Centers - Beech Grove Campus	Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Daniel P. McKellar, MD 937-832-9310
Veterans Affairs Medical Center - Indianapolis	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Virgilio George 317-554-0000
William N. Wishard Memorial Hospital	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Virgilio George 317-639-6671
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation	Recruiting
New Orleans, Louisiana, United States, 70121
Contact: David A. Margolin 504-842-4360
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: James W. Fleshman 314-747-7222
United States, Ohio
Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422
CCOP - Dayton	Recruiting
Dayton, Ohio, United States, 45429
Contact: Daniel P. McKellar, MD 937-832-9310
Charles F. Kettering Memorial Hospital	Recruiting
Kettering, Ohio, United States, 45429
Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita 937-298-3399 ext. 57556
David L. Rike Cancer Center at Miami Valley Hospital	Recruiting
Dayton, Ohio, United States, 45409
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami 937-208-2079
Good Samaritan Hospital	Recruiting
Dayton, Ohio, United States, 45406
Contact: Daniel P. McKellar, MD 937-832-9310
Grandview Hospital	Recruiting
Dayton, Ohio, United States, 45405
Contact: Daniel P. McKellar, MD 937-832-9310
Middletown Regional Hospital	Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Daniel P. McKellar, MD 937-832-9310
Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Recruiting
Xenia, Ohio, United States, 45385
Contact: Daniel P. McKellar, MD 937-832-9310
UVMC Cancer Care Center at Upper Valley Medical Center	Recruiting
Troy, Ohio, United States, 45373-1300
Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall 937-440-4842
Veterans Affairs Medical Center - Dayton	Recruiting
Dayton, Ohio, United States, 45428
Contact: Daniel P. McKellar, MD 937-832-9310
United States, Oregon
Providence Cancer Center at Providence Portland Medical Center	Recruiting
Portland, Oregon, United States, 97213-2967
Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412
United States, Texas
M. D. Anderson Cancer Center at University of Texas	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

James W. Fleshman, MD

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000601816, ACOSOG-Z6051
Study First Received:	July 31, 2008
Last Updated:	January 10, 2009
ClinicalTrials.gov Identifier:	NCT00726622
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009