Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer

• Circumferential margin > 1 mm [ Designated as safety issue: No ]
• Negative distal resected margin [ Designated as safety issue: No ]
• Completeness of total mesorectal excision (complete or nearly complete) [ 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 ]

RATIONALE: Laparoscopic-assisted resection is a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether laparoscopic-assisted resection is more effective than open resection in treating patients with rectal cancer.

PURPOSE: This randomized phase III trial is studying laparoscopic-assisted resection to see how well it works compared with open resection in treating patients with stage IIA, stage IIIA, or stage IIIB rectal cancer.

OBJECTIVES:

Primary

• To test the hypothesis that laparoscopic-assisted resection is not inferior to open resection, based on a composite primary endpoint of oncologic factors that are indicative of a safe and feasible surgical resection, in patients with stage IIA, IIIA, or IIIB rectal cancer.

Secondary

• To compare the patient-related benefit of laparoscopic-assisted resection vs open resection, in terms of blood loss, length of stay, and utilization of pain medication.
• To compare the disease-free survival and local pelvic recurrence at 2 years.
• To compare the quality of life, sexual function, and bowel and stoma function.

OUTLINE: This is a multicenter study. Patients are stratified according to site of primary tumor (high vs middle vs low rectum), registering surgeon, and planned operative procedure (low anterior resection vs abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo open laparotomy and rectal resection.
• Arm II: Patients undergo laparoscopic-assisted rectal resection. Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), the Linear Analog Self-Assessment (LASA), the Stoma Quality of Life Scale (SQOLS), and the Mayo Bowel Function Questionnaire (MBFQ).

After completion of study treatment, patients are followed periodically for up to 5 years.

• Procedure: therapeutic conventional surgery
  Patients undergo open laparotomy and rectal resection.
• Procedure: therapeutic laparoscopic surgery
  Patients undergo laparoscopic-assisted rectal resection.

• Active Comparator: Arm I
  Patients undergo open laparotomy and rectal resection.
  Intervention: Procedure: therapeutic conventional surgery
• Experimental: Arm II
  Patients undergo laparoscopic-assisted rectal resection.
  Intervention: Procedure: therapeutic laparoscopic surgery

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the rectum (≤ 12 cm from the anal verge)

  • T3, N0, M0 or T1-3, N1-2, M0 disease by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound

    • No T4 disease

• Must have completed neoadjuvant fluorouracil-based chemotherapy and/or radiotherapy within the past 4 weeks

  • Capecitabine may have been substituted for fluorouracil

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Body mass index ≤ 34
• Negative pregnancy test
• No evidence of conditions (e.g., multiple prior major laparotomies or severe adhesions) that would preclude use of a laparoscopic approach
• No systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude surgery
• No other severe incapacitating disease (i.e., ASA IV [severe systemic disease that is a constant threat to life] or ASA V [moribund and is not expected to survive without the operation])
• No other invasive pelvic malignancy (cervical, uterine, or rectal) within the past 5 years
• 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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics