Upstate Active Clinical Trials Seeking Participants
Study title
Study Title: Z6051: A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer
IRB number
CIRB122
What is the purpose of the study?
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. The two types of surgery are described below. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, there are still questions about whether this type of surgery is as effective as open surgery.
Some research results suggest laparoscopic-assisted rectal resection could be an alternative to open laparotomy rectal resection for patients with rectal cancer, but today we do not know how the two compare. The results of this study will help make that comparison. We do not know whether laparoscopic-assisted rectal resection will be more effective, less effective or about the same as open laparotomy rectal resection. We do not know whether laparoscopic resection of rectal cancer will have any effect, positive or negative, on your overall health and quality of life.
This study will compare:
" Safety and effectiveness of the surgeries: ability to remove the entire tumor plus an appropriate margin of surrounding tissue; amount of blood loss during surgery
" Recovery from surgery in the hospital: amount of pain medication required; length of hospital stay, nature of any surgical complications (problems)
" Overall recovery from surgery: general quality of life, sexual function, bowel function
" Cancer outcome: recurrence of cancer in the pelvis or other parts of the body
Who is eligible?
1. Histologic diagnosis of adenocarcinoma of the rectum (<12cm from the anal verge).
2. T3N0M0, T1-3N1-2M0 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. NOTE: The same value applies to both male and female patients.
7. No evidence of conditions that would preclude use of a laparoscopic approach (e.g., multiple previous major laparotomies, severe adhesions).
8. No systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery. No other severe incapacitating disease, i.e., 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. Non-pregnant and non-lactating, as confirmed by pre-treatment pregnancy test for patients of childbearing potential. Patients must be amenorrheic for > 12 months to be considered not of child-bearing potential.
10. No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
11. 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.
What is involved if I participate?
- How long is the study?
Postoperative contact will include a visit in the hospital or office at 3 days, one to two weeks, four to six weeks, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after surgery. Long-term follow-up will be conducted annually for an additional 3 years. Follow-up may be conducted through the patients local physician, per surgeon discretion. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Surgery for colon resection
Who is the doctor administering the study?
Jiri Bem MD
Where will the study take place?
SUNY Upstate Hospital, 550 Harrison Center
Over what time period is the study scheduled to run?
2010 to unknown
Who can I contact for more information?
- Name: Linda Ellinwood
- Phone: 315-464-1852
- Email: ellinwol@upstate.edu
- Fax: 315-464-6234
If you are interested in this trial, please contact the study coordinator or investigator noted above.
