Status:
TERMINATED
Chemotherapy or Not, Following Complete Treatment of Hepatic Cancer in Cirrhotic Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Liver Neoplasms
Liver Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 can...
Detailed Description
The best treatment for hepatocellular carcinoma (HCC) with cirrhosis, currently is liver transplantation because treating the cancer and the causal disease. For the majority of patients, transplantati...
Eligibility Criteria
Inclusion
- Hepatocellular carcinoma (histology or Barcelona criteria) curatively treated by surgical resection or by radiofrequency or by cryotherapy
- Evidence of liver cirrhosis (clinical, biological, endoscopic or histological criteria)
- Morphological evaluation 4 to 6 weeks following curative treatment
- No evidence of local or distant disease on the morphological evaluation
- Absence of peritoneal or lymph node metastasis
- Absence of pre- or per-operative macroscopic tumoral thrombus
- Minimal free margin of 5 mm following pathological exam
- ALPHAAFOETOPROTEINE level of less than 4 normal values or decreased by 50%, 4 to 6 weeks following curative treatment
- Biological criteria, 2 weeks before treatment as follow:
- neutrophilic polymorphonuclear \> 1500/mm3,
- platelets \> 100 000/mm3,
- total bilirubin \< 25 mmol/l (1.46 mg/dl),
- creatinin \< 1.5 x normal value
- Eastern Cooperative Oncology Group (ECOG) equal to 0 or 1
- Life expectancy \> 12 weeks
- Absence of sensitive neuropathy at inclusion time
- Health insurance coverage
- Efficient contraceptive method if applicable
- Signed informed consent
Exclusion
- Curative treatment performed 10 weeks or more before the beginning of adjuvant treatment
- Contraindication to an angiography or hepatic artery thrombosis or portal thrombosis.
- Pregnant or breastfeeding woman
- Concomitant involvement to any clinical trial
- Decompensate cirrhosis and Child-Pugh score ≥ 8 or clinical ascitis.
- Cancer of the Liver Italian Program (C.L.I.P.) score ≥ 2
- Heart or lung insufficiency
- Other cancer not considered as definitively cured
- Creatinin clearance \< 30 ml/min
- Recurrence of HCC less than 12 months following any last treatment
- Any radiotherapy during the 4 weeks before inclusion
- Known sensitivity to any drug of this protocol
- Immunodeficiency (HIV+, transplanted patient)
- Inability of follow up
- Impossibility of clear understanding of the protocol for no french speaking patient
- Patient under legal protection
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00470340
Start Date
June 1 2007
End Date
November 1 2008
Last Update
May 5 2011
Active Locations (1)
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1
Urc La Pitie Salpetriere,
Poissy, France, 75013