Trial Information
Summary: Randomized phase III study for stage II colon cancer at high risk for recurrence
Comparing 5-FU, leucovorin and Oxalplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab to determine prospectively the prognostic value of molecular markers
A marker evaluation of your tumor will be done if it
demonstrates you to be at low-risk for tumor recurrence, then you
will have regular follow-up to monitor your health, but will not
receive any further treatment for the cancer including
chemotherapy.
If the tumor marker shows high-risk for tumor recurrence the you
will be randomized into one of two study groups.
Arm A standard regimen of
chemotherapy 5-FU/leucovorin/oxaliplatingiven on days 1 and 2 every
2 weeks for a total of 12 cycles
Arm B standard two-day regimen of chemotherapy
5-FU/leucovorin/oxaliplatin given on days 1 and 2, every two weeks
for a total of 12 cycles
You will also receive bevacizumab on day 1 every two weeks
Patient Inclusion Criteria:
- Stage II colon adenocarcinoma
- Patients must have greater and/or equal 8 lymph nodes
evaluated
- Patients must not have had any systemic or radiation
therapy
- Patients must be 18 or older
- Patients must have good performance status
Patient Exclusion Criteria:
- Surgery past 60 days from day of registration
- Pregnant and/or nursing
- Patients with non-malignant systemic disease (cardiovascular,
renal, hepatic, etc.) that would preclude them from receiving the
drugs
- Patients with psychiatric or addictive disorders
Primary Outcomes:
To demonstrate disease free
survival
To prospectively determine the impact of tumor biological
characteristics on the survival of patients with stage II colon
cancer
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Contact:
Janeen V. Bazan, Oncology Research Nurse and Program Coordinator
Sherman Health Systems
934 Center Street
Elgin, IL 60120
Telephone: 847-429-2907
Fax: 847-429-3071
Email:
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Trial listings updated: June 1, 2008 at 5:45:50 AM