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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCI, OtherCDR0000601816
ACOSOG-Z6051, U10CA076001, NCI-2009-00350, Z6051, NCT00726622

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

James W. Fleshman, MDStudy Chair

Trial Sites

U.S.A.
Florida
  Weston
 Cleveland Clinic Florida - Weston
 Steven D Wexner Ph: 954-659-5705
Georgia
  Atlanta
 CCOP - Atlanta Regional
 Thomas E. Seay Ph: 404-303-3355
 Northside Hospital Cancer Center
 Thomas E. Seay Ph: 404-303-3355
 Piedmont Hospital
 Thomas E. Seay Ph: 404-303-3355
 Saint Joseph's Hospital of Atlanta
 Thomas E. Seay Ph: 404-303-3355
  Decatur
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 Thomas E. Seay Ph: 404-303-3355
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Dipen C Maun Ph: 317-834-2020
Ohio
  Cleveland
 Case Comprehensive Cancer Center
 Conor P Delaney Ph: 800-641-2422
Utah
  American Fork
 American Fork Hospital
 Mark J Ott Ph: 801-507-3950
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 Mark J Ott Ph: 801-507-3950
  Ogden
 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
 Mark J Ott Ph: 801-507-3950
  Provo
 Utah Valley Regional Medical Center - Provo
 Mark J Ott Ph: 801-507-3950
  Saint George
 Dixie Regional Medical Center - East Campus
 Mark J Ott Ph: 801-507-3950
  Salt Lake City
 LDS Hospital
 Mark J Ott Ph: 801-507-3950
 Utah Cancer Specialists at UCS Cancer Center
 Mark J Ott Ph: 801-507-3950
Wisconsin
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Sam G Pappas Ph: 414-805-3666

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00726622
ClinicalTrials.gov processed this data on May 13, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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