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

NCT00726622 | Completed Phase 3 Results DMC

• 4 other identifiers: ACOSOG-Z6051U10CA076001NCI-2009-00350CDR0000601816
• Study Type: interventional
• Target: 486
• Locations: 2 countries
• Sites: 37

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.

Conditions

Colorectal Cancer

Keywords

rectal cancer; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

• Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.

  The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation. Primary endpoint parameters: * Circumferential margin \> 1 mm * Negative distal margin * Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat. All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior.

  At time of Surgery

Secondary Outcomes (12)

• Completeness of Total Mesorectal Excision (Complete or Nearly Complete)

  At time of surgery

• Negative Distal Resected Margin

  At time of surgery

• Circumferential Margin > 1 mm

  At time of surgery

• Length of Stay

  Two weeks post-surgery

• Use of Pain Medication

  Two weeks post-surgery

Study Arms (2)

Arm 1: Open laparotomy and rectal resection

ACTIVE COMPARATOR

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.

Procedure: Open laparotomy and rectal resection

Arm 2: Laparoscopic-assisted rectal resection

EXPERIMENTAL

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.

Procedure: Laparoscopic-assisted rectal resection

Interventions

Open laparotomy and rectal resection PROCEDURE

Patients undergo open laparotomy and rectal resection.

Arm 1: Open laparotomy and rectal resection

Laparoscopic-assisted rectal resection PROCEDURE

Patients undergo laparoscopic-assisted rectal resection.

Arm 2: Laparoscopic-assisted rectal resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Eligibility Criteria: 1. Histologic diagnosis of adenocarcinoma of the rectum (≤ 12 cm from the anal verge) 2. T3, N0, M0, T1-3, N1-2, M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible. 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (37)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, 94524-4110, United States

Location

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, 90027, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

John Muir/Mt. Diablo Comprehensive Cancer Center

Walnut Creek, California, 94598, United States

Location

Cleveland Clinic Florida - Weston

Weston, Florida, 33331, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Clarian North Medical Center

Carmel, Indiana, 46032, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Veterans Affairs Medical Center - Indianapolis

Indianapolis, Indiana, 46202, United States

Location

William N. Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

Kendrick Regional Center for Colon and Rectal Care - Mooresville

Mooresville, Indiana, 46158, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, 01805, United States

Location

Blodgett Hospital at Spectrum Health

Grand Rapids, Michigan, 49506, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Boone Hospital Center

Columbia, Missouri, 65201, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Overlook Hospital

Summit, New Jersey, 07901, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-9446, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

INTEGRIS Cancer Institute of Oklahoma - Proton Campus

Oklahoma City, Oklahoma, 73142, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Forbes Regional Hospital

Monroeville, Pennsylvania, 15146, United States

Location

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224-1791, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

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

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St. Joseph's Hospital - Charlton Campus

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 26441179 DERIVED

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Tonia M. Young-Fadok, M.D.
• Organization: Mayo Clinic

youngfadok.tonia@mayo.edu

Study Officials

• James W. Fleshman, MD

  Baylor Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 1, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: August 1, 2019
• Last Updated: May 7, 2020
• Results First Posted: November 11, 2016

Record last verified: 2020-04

Locations

CA (2); US (35)