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Therapeutic Areas: Oncology | Gastroenterology
Disease Category: Colon Cancer
Trial Information
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
Janeen V. Bazan, Oncology Research Nurse and Program Coordinator
Sherman Health Systems
934 Center Street
Elgin, IL 60120
Phone: 847-429-2907
Fax: 847-429-3071
EMail: janeen.bazan@shermanhospital.org
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Research Center Information: Sherman Health Systems
If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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