A randomised phase II study of doxorubicin combined with thalidomide versus doxorubicin alone for patients with unresectable hepatocellular carcinoma

ISRCTN	ISRCTN53872240
DOI	https://doi.org/10.1186/ISRCTN53872240
Secondary identifying numbers	NTR411; EMC 04-046

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 03/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S. Sleijfer
Scientific

Erasmus MC - Daniel den Hoed
Department of Medical Oncology
Groene Hilledijk 301
Rotterdam
3075 EA
Netherlands

Study information

Study design	Randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	HCC
Study objectives	Previous trials showed that both doxorubicin and thalidomide have anti-tumour activity against hepatocellular carcinoma (HCC). There are indications that these two agents interact synergistically and have non-overlapping toxicity profiles. This trial studies the feasibility and efficacy of doxorubicin combined with thalidomide for the treatment of hepatocellular carcinoma, compared with doxorubicin as single agent.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Hepatocellular cancer
Intervention	Control arm: doxorubicin 60 mg/m^2 day 1, three weekly course with in total 6 cycles (maximum 360 mg/m2) given intravenously in 15 minutes. Experimental arm: doxorubicin treatment as in control arm plus from day 3 on, thalidomide 200 mg daily administered in the evening. When doxorubicin administration has finished, thalidomide should be continued until progression of disease.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Doxorubicin, thalidomide
Primary outcome measure	One-year survival
Secondary outcome measures	1. Response rate scored according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 2. Time to progression 3. Quality of life 4. Toxicity
Overall study start date	17/06/2004
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	30
Key inclusion criteria	1. Histologically proven HCC 2. Irresectable tumour 3. Failure to previous treatment 4. World Health Organization (WHO) performance status 0 - 2 5. At least 4 weeks since prior treatment with HMG-Coa reductase inhibitors or systemic immunosuppresiva 6. Adequate hepatic and bone marrow function
Key exclusion criteria	1. Prior treatment with doxorubicin or thalidomide 2. Uncontrolled hypertension 3. Unstable angina 4. Arrhythmias requiring treatment 5. Myocardial infarction (MI) 6. Thrombo-embolic events requiring treatment 7. Congestive heart failure or cardiomyopathy requiring treatment 8. Peripheral neuropathy
Date of first enrolment	17/06/2004
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus MC - Daniel den Hoed

Rotterdam
3075 EA
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
Hospital/treatment centre

Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Website	http://www.erasmusmc.nl/content/englishindex.htm
"ROR"	https://ror.org/018906e22

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan