Status:
WITHDRAWN
FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma
Lead Sponsor:
Sirtex Medical
Conditions:
Colorectal Carcinoma
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known ...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the colon or rectum.
- Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent.
- ECOG performance status 0 - 1.
- Adequate hematological, renal and hepatic function.
Exclusion
- Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment.
- Any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. Central nervous system (CNS) metastases are not allowed.
- Previous radiotherapy delivered to the upper abdomen.
- Peripheral neuropathy \> grade 1 (NCI-CTCv3).
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00735241
Start Date
July 1 2008
End Date
March 1 2009
Last Update
May 22 2015
Active Locations (3)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
2
Carolinas Medical Center
Charlotte, North Carolina, United States, 28208
3
Sacred Heart Medical Center
Spokane, Washington, United States, 99204