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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00726622
First received: July 31, 2008
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Procedure: Open laparotomy and rectal resection
Procedure: Laparoscopic-assisted rectal resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Circumferential margin > 1 mm [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Negative distal resected margin [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Completeness of total mesorectal excision (complete or nearly complete) [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-related benefit (length of stay, operative times and use of pain medication) [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: Up to 2 years post surgery ] [ Designated as safety issue: No ]
  • Local pelvic recurrence rates [ Time Frame: Up to 2 years post surgery ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
  • Quality of life and sexual function [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
  • Bowel function [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
  • Bowel and stoma function [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]

Enrollment: 486
Study Start Date: August 2008
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: Open laparotomy and rectal resection
Patients undergo open laparotomy and rectal resection.
Experimental: 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.
Procedure: Laparoscopic-assisted rectal resection
Patients undergo laparoscopic-assisted rectal resection.

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.

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 37 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: James W. Fleshman, MD Baylor Health
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00726622     History of Changes
Other Study ID Numbers: CDR0000601816, ACOSOG-Z6051, U10CA076001, NCI-2009-00350
Study First Received: July 31, 2008
Last Updated: May 13, 2014
Health Authority: United States: NCI Central Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
rectal cancer
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 29, 2014