Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer

NCT ID: NCT00726622

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 486 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2019-08-01

Brief Summary

This study is being done to compare two types of surgery currently used for rectal cancer. The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, the effectiveness of this type of surgery compared to open surgery is unknown. The study will compare the safety and effectiveness of the surgeries, recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.

Detailed Description

This is a multicenter study. Patients eligible for this trial will have completed 5FU based neoadjuvant chemotherapy/radiation therapy per the institution's standard of care or IRB approved clinical trial. Patients may be registered/randomized anytime after completion of neoadjuvant therapy, but surgery must occur within 4-12 weeks (28-84 days) after completion of neoadjuvant therapy. Patients are stratified according to the site of the primary tumor (high, middle or low rectum), registering surgeon, and planned operative procedure (low anterior resection or abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more details. The primary and secondary objectives are listed below.

Primary Objective:

To test the hypothesis that laparoscopic-assisted resection for rectal cancer is not inferior to open rectal resection, based on a composite primary endpoint of oncologic factors which are indicative of a safe and feasible operation.

Secondary Objectives:

1. To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs.

open rectal resection (blood loss, length of stay, pain medicine utilization)

2. To assess disease free survival and local pelvic recurrence at two years.

3. To assess quality of life, sexual function, bowel and stoma function at scheduled time points throughout the trial.

Patients will be evaluated after surgery to determine the need for subsequent care based on the final pathology. Patients should not start treatment on any other investigative trial involving intervention or invasive diagnostic procedures ≤ 30 days following surgery to enable a complete evaluation of post-operative adverse events and complications occurring within 30 days of surgery. Patients are followed periodically for up to 5 years post surgery.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Open laparotomy and rectal resection

Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.

Group Type: ACTIVE_COMPARATOR

Open laparotomy and rectal resection

Intervention Type: PROCEDURE

Patients undergo open laparotomy and rectal resection.

Arm 2: Laparoscopic-assisted rectal resection

Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.

Group Type: EXPERIMENTAL

Laparoscopic-assisted rectal resection

Intervention Type: PROCEDURE

Patients undergo laparoscopic-assisted rectal resection.

Interventions

Open laparotomy and rectal resection

Patients undergo open laparotomy and rectal resection.

Intervention Type: PROCEDURE

Laparoscopic-assisted rectal resection

Patients undergo laparoscopic-assisted rectal resection.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

3. Completion of pre-operative 5FU based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.

4. Age ≥ 18 years

5. ECOG (Zubrod) Performance Status ≤ 2

6. Body Mass Index (BMI) ≤ 34

7. No evidence of conditions that would preclude use of a laparoscopic approach (eg, multiple previous major laparotomies, severe adhesions)

8. No systemic disease (cardiovascular, renal, hepatic) that would preclude surgery. No other severe incapacitating disease:

• ASA IV: A patient with severe systemic disease that is a constant threat to life. OR
• ASA V: A moribund patient who is not expected to survive without the operation.

9. No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration

10. 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.

NOTE: Incompetent patients are not eligible for this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James W. Fleshman, MD

Role: STUDY_CHAIR

Baylor Health

Locations

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, United States

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, United States

California Pacific Medical Center - California Campus

San Francisco, California, United States

John Muir/Mt. Diablo Comprehensive Cancer Center

Walnut Creek, California, United States

Cleveland Clinic Florida - Weston

Weston, Florida, United States

John B. Amos Cancer Center

Columbus, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Evanston Hospital

Evanston, Illinois, United States

Clarian North Medical Center

Carmel, Indiana, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Veterans Affairs Medical Center - Indianapolis

Indianapolis, Indiana, United States

William N. Wishard Memorial Hospital

Indianapolis, Indiana, United States

Kendrick Regional Center for Colon and Rectal Care - Mooresville

Mooresville, Indiana, United States

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, United States

Blodgett Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Boone Hospital Center

Columbia, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Overlook Hospital

Summit, New Jersey, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Stony Brook University Cancer Center

Stony Brook, New York, United States

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

INTEGRIS Cancer Institute of Oklahoma - Proton Campus

Oklahoma City, Oklahoma, United States

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, United States

Forbes Regional Hospital

Monroeville, Pennsylvania, United States

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

St. Paul's Hospital at Providence Health Care - Vancouver

Vancouver, British Columbia, Canada

St. Joseph's Hospital - Charlton Campus

Hamilton, Ontario, Canada

Countries

United States; Canada

References

Fleshman J, Branda M, Sargent DJ, Boller AM, George V, Abbas M, Peters WR Jr, Maun D, Chang G, Herline A, Fichera A, Mutch M, Wexner S, Whiteford M, Marks J, Birnbaum E, Margolin D, Larson D, Marcello P, Posner M, Read T, Monson J, Wren SM, Pisters PW, Nelson H. Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1346-55. doi: 10.1001/jama.2015.10529.

Reference Type: DERIVED

PMID: 26441179 (View on PubMed)

Related Links

https://nctn-data-archive.nci.nih.gov/

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Other Identifiers

ACOSOG-Z6051

Identifier Type: -

Identifier Source: secondary_id

U10CA076001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00350

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000601816

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACOSOG-Z6051

Identifier Type: -

Identifier Source: org_study_id