Status:
COMPLETED
Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. Alt...
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 t...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Histologic diagnosis of adenocarcinoma of the rectum (≤ 12 cm from the anal verge)
- 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.
- Completion of pre-operative 5FU based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
- Age ≥ 18 years
- ECOG (Zubrod) Performance Status ≤ 2
- Body Mass Index (BMI) ≤ 34
- No evidence of conditions that would preclude use of a laparoscopic approach (eg, multiple previous major laparotomies, severe adhesions)
- 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.
- No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT00726622
Start Date
August 1 2008
End Date
August 1 2019
Last Update
May 7 2020
Active Locations (37)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States, 94524-4110
3
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States, 90027
4
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118