drugset / Trial / NCT00470340

Chemotherapy or Not, Following Complete Treatment of Hepatic Cancer in Cirrhotic Patients

NCT00470340

Phase 3 Terminated 263 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelPrevention

Summary

Besides liver transplantation, the curative treatment of primary hepatic cancer with cirrhosis remains the surgical resection. Radiofrequency or cryotherapy currently allow local ablation of small cancer, with very good results. However, all these treatments are followed by high rates of recurrence (50 - 70% at 5 years). Then, it seems essential to associate to the surgical resection or to the local ablation as "adjuvant" treatment, in order to prevent or to decrease the rate of recurrence. However, no evidence supports this attitude. Therefore, following curative treatment of primary hepatic cancer with cirrhosis, we propose to compare treated to untreated patients. Postoperative treatment means either intra-arterial chemotherapy or systemic chemotherapy. The main criterion of the study is time of survival without recurrence. The main secondary objective is the safety.

Timeline

Start
2007-06
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg Intrathecal
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous
Background lipiodol Unknown 10 ml Intrathecal