| Ad Title: |
A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliiplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers - E5202 |
| Study Title: |
A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliiplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers |
| Protocol Number: |
102007-077 |
| Department(s) involved in the Study: |
Simmons Comprehensive Cancer Center
|
| Purpose of the Study: |
To demonstrate an improvement in 3-year disease free survival for high-risk stage II colon cancer patients randomly assigned to 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX) versus FOLFOX and bevacizumab. |
| Participant Eligibility: |
Eligible participants must be 18 or older and exhibit the following:
1. Distal extent of colon cancer tumor must be greater than or equal to 12 cm from the anal verge on endoscopy, less than 50 days post-operative.
2. Tumor specimen available for evaluation to determine high risk vs. low risk.
3. Must not have synchronous tumors, appendiceal tumors, isolated, distant or non-continguous intra-abdominal metastases even if restricted, nor have a history or inflammatory bowel syndrome (IBD).
4. Patients must not have clinical complete obstruction or perforation of the bowel.
Patients must sign informed consent, have an ECOG Performance Status of 0-2 and comply with all study requirements. Spanish speaking patients are eligible to participate. |
| Disease/Condition Under Study: |
Colon Cancer |
| Cancer Related Study: |
Yes
|
| Study Drug(s): |
5-FU (Adrucil, Efudex, 5-fluorouracil), Leucovorin, Oxaliplatin (Eloxatin)
|
| Study Device(s): |
|
| Study Doctor: |
Dr. James Willson |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
UT Southwestern University Hospitals St. Paul Building
|
Yes
|
|
UT Southwestern University Hospitals Zale Lipshy Building
|
Yes
|
|
UT Southwestern Medical Center
|
Yes
|
|
| Contact Phone: |
214-648-5107 |
| Email: |
dendra.vonmerveldt@utsouthwestern.edu |
| Other Information: |
Please call to receive further information regarding eligibility criteria for study. |
| Website Keywords: |
Colorectal Cancer, Colorectal Conditions
|
| Medical Keywords: |
colon cancer
|
