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

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:

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.