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Completed
NCT01677884
Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy
Conditions: Colorectal Neoplasms
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 10
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Location: Institut Gustave Roussy Villejuif Val de Marne
Summary
The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1)
Eligibility Criteria
Inclusion Criteria:
* Liver metastases of colon cancer or rectal predominant (histological evidence obtained on the primary tumor or liver metastases)
* Isolated (no extra-hepatic metastasis, primary tumor resected)
* No access to curative hepatectomy (R0 resection foreseeable or not leaving less than 30% residual non-tumor liver normally vascularized), or requiring complex hepatectomy, very large (5 or more segments) and / or risked (class II CPP)
* which at least one measurable by RECIST (\>2 cm, or \>1 cm if Computed tomography (CT) spiraled)
* Or extra-hepatic disease of small size potentially accessible to a resection (one or two lung metastases, lymphadenopathy localized accessible to curative resection)
* colon or rectal primary tumor : resected or asymptomatic
* Progression after first line chemotherapy to treat the metastatic disease, all types of treatment allowed except intra-arterial Bevacizumab
* Age \>18 years \3 months
* Bilirubin \150/100 mm Hg despite hypertensive treatment)
* Heart Failure \>Grade II of the New York Heart Association (NYHA) (class II-III-IV)severe renal failure
* History and / or presence of bleeding disorders and/or thrombotic \
Source: ClinicalTrials.gov (NCT01677884). StuddyBuddy aggregates publicly available trial information.