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

NCT00470340 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2011-05-05

No results posted yet for this study

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.

Conditions

  • Liver Neoplasms
  • Liver Cirrhosis
  • Carcinoma, Hepatocellular
  • Recurrence
  • Neoplasm Recurrence, Local

Interventions

DRUG

Oxaliplatin, gemcitabine, cisplatin, lipiodol

Oxaliplatin, gemcitabine, cisplatin, lipiodol

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Eric Savier, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00470340 on ClinicalTrials.gov