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

NCT00470340 | Terminated Phase 3 DMC

• 1 other identifier: P051062
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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 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

Keywords

Recurrence; Neoplasm Recurrence, Local; Liver; Liver Neoplasms; Liver Cirrhosis; Carcinoma, Hepatocellular; Iodized Oil; gemcitabine [Substance Name]; oxaliplatin [Substance Name]; gemcitabine-oxaliplatin regimen [Substance Name]; Randomized Controlled Trials; Multicenter Studies; Cisplatin; Injections, Intra-Arterial; Injections, Intravenous; Chemotherapy, Adjuvant

Outcome Measures

Primary Outcomes (1)

• Survival without recurrence at 2 years

  2 years

Secondary Outcomes (1)

• Morbidity and mortality following adjuvant treatment

  at 6 months

Study Arms (2)

1

EXPERIMENTAL

Oxaliplatin, gemcitabine, cisplatin, lipiodol

Drug: Oxaliplatin, gemcitabine, cisplatin, lipiodol

2

EXPERIMENTAL

Oxaliplatin, gemcitabine, cisplatin, lipiodol

Drug: Oxaliplatin, gemcitabine, cisplatin, lipiodol

Interventions

Oxaliplatin, gemcitabine, cisplatin, lipiodol DRUG

Oxaliplatin, gemcitabine, cisplatin, lipiodol

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Urc La Pitie Salpetriere,

Poissy, 75013, France

Location

MeSH Terms

Conditions

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

Interventions

Oxaliplatin; Gemcitabine; Cisplatin; Ethiodized Oil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Eric Savier, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 5, 2011

Record last verified: 2007-05

Locations

FR (1)