Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000090415
Ethics application status
Not yet submitted
Date submitted
23/11/2006
Date registered
29/01/2007
Date last updated
29/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase II Trial of Temozolomide and Caelyx in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy
Scientific title
Phase II Trial of Temozolomide and Caelyx in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy to improve six month progression free survival
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 1588 0
Condition category
Condition code
Cancer 1690 1690 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase II Trial of six months of oral Temozolomide (200mg/m2 days 1-5, q4 weekly) and intravenous liposomal doxorubicin (40mg/m2 q 4 weekly) (Caelyx) in standard doses in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy to improve six month progression free survival.
Intervention code [1] 1462 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Historical

Outcomes
Primary outcome [1] 2343 0
Six month progression free survival following commencement of therapy.
Timepoint [1] 2343 0
6 months.
Secondary outcome [1] 4076 0
Toxicity
Timepoint [1] 4076 0
during the course of treatment and for 30 days post completion

Eligibility
Key inclusion criteria
Inclusion: Newly diagnosed glioblastoma, performance status 0-2, completed post-operative concurrent radiotherapy/chemotherapy.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion: significant co-morbidities

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1831 0
Commercial sector/Industry
Name [1] 1831 0
Schering-Plough
Country [1] 1831 0
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough
Address
Country
Secondary sponsor category [1] 1650 0
None
Name [1] 1650 0
None
Address [1] 1650 0
Country [1] 1650 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3428 0
Currently under review by Royal Melbourne
Ethics committee address [1] 3428 0
Ethics committee country [1] 3428 0
Australia
Date submitted for ethics approval [1] 3428 0
Approval date [1] 3428 0
Ethics approval number [1] 3428 0

Summary
Brief summary
Standard of care post surgery for GBM is concurrent radiotherapy/chemotherapy followed by 6 months of chemotherapy (temozolomide). We have previously shown that the combination of Temozolomide with liposomal doxorubicin (caelyx) has activity in recrurrent GBM and is well tolerated. This study aims to assess whether the addition of liposomal doxorubicin to six months of post RT temozolomide is efficacious and well tolerated
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27396 0
Address 27396 0
Country 27396 0
Phone 27396 0
Fax 27396 0
Email 27396 0
Contact person for public queries
Name 10651 0
Professor Mark Rosenthal
Address 10651 0
Department of Medical Oncology
Royal Melbourne Hospital
Grattan Street
VIC 3050
Country 10651 0
Australia
Phone 10651 0
+61 3 93427695
Fax 10651 0
+61 3 93477508
Email 10651 0
[email protected]
Contact person for scientific queries
Name 1579 0
Professor Mark Rosenthal
Address 1579 0
Department of Medical Oncology
Royal Melbourne Hospital
Grattan Street
VIC 3050
Country 1579 0
Australia
Phone 1579 0
+61 3 93427695
Fax 1579 0
+61 3 93477508
Email 1579 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.