Condition category
Cancer
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S. Sleijfer

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR411; EMC 04-046

Study information

Scientific title

Acronym

HCC

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Doxorubicin, thalidomide

Primary outcome measures

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 trial start date

17/06/2004

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30

Participant 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

Recruitment start date

17/06/2004

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC - Daniel den Hoed
Rotterdam
3075 EA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes