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

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Cisplatin; Ethiodized Oil; Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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