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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00726622
First received: July 31, 2008
Last updated: September 23, 2016
Last verified: August 2016

July 31, 2008
September 23, 2016
August 2008
October 2013   (final data collection date for primary outcome measure)
Non-Inferiority Analysis Between Laparoscopic-assisted Resection and Open Rectal Resection for Rectal Cancer. [ Time Frame: At time of Surgery ] [ Designated as safety issue: No ]

The primary aim is to test the hypothesis that laparoscopic-assisted resection for rectal cancer is not inferior to open rectal resection. 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 defined as 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. A nearly complete TME is defined as a rectal resection specimen where the mesentery is all present, without coning or missing fat. A <5 mm deep defect may be present in the envelope covering mesenteric fat.
  • 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 ]
Complete list of historical versions of study NCT00726622 on ClinicalTrials.gov Archive Site
  • Completeness of Total Mesorectal Excision (Complete or Nearly Complete) [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

    Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.

    The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI.

  • Negative Distal Resected Margin [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    The percentage of patients with negative distal margin (>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binoimial 95% confidence intervals.
  • Circumferential Margin > 1 mm [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with >1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.
  • Length of Stay [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
    The mean number of days required post-surgery to the when the patient was released from the hospital wascalculated.
  • Use of Pain Medication [ Time Frame: Up to 5 years post surgery ] [ Designated as safety issue: No ]
    The number of days patients received parenteral narcotics post-surgery were counted.
  • Operative Times [ Time Frame: During surgery ] [ Designated as safety issue: No ]
    Open to close operative time.
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer
A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Procedure: Open laparotomy and rectal resection
    Patients undergo open laparotomy and rectal resection.
  • Procedure: Laparoscopic-assisted rectal resection
    Patients undergo laparoscopic-assisted rectal resection.
  • 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.
    Intervention: Procedure: 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.
    Intervention: Procedure: Laparoscopic-assisted rectal resection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
486
Not Provided
October 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00726622
ACOSOG-Z6051, ACOSOG-Z6051, U10CA076001, NCI-2009-00350, CDR0000601816
Yes
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: James W. Fleshman, MD Baylor Health
Alliance for Clinical Trials in Oncology
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP