Phase III trial of the anti-angiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy

ISRCTN	ISRCTN13632914
DOI	https://doi.org/10.1186/ISRCTN13632914
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr D Storm
Scientific

The Netherlands Cancer Center
NVALT Trial Desk
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands

Study design	Randomised, controlled, factorial, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	NVALT5
Study objectives	Maintenance thalidomide delays the time to progression with 50% in patients who do not progress after more than three cycles of pemetrexed containing chemotherapy.
Ethics approval(s)	Approval received from the local ethics board (De Protocol Toetsingscommissie van het Nederlands Kanker Instituut Antoni van Leeuwenhoek Ziekenhuis [PTC]) on the 14th January 2004 (ref: PTC04.074).
Health condition(s) or problem(s) studied	Malignant mesothelioma
Intervention	Thalidomide 200 mg orally at night for up to one year with best supportive care or observation alone with best supportive care.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Thalidomide
Primary outcome measure	Increase of five to 7.5 months for time to recurrence.
Secondary outcome measures	Toxicity (neurologic and thrombo-embolic).
Overall study start date	09/09/2004
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	216
Key inclusion criteria	1. Good condition (Eastern Cooperative Oncology Group [ECOG] Performance Status [PS] zero to two) 2. First line therapy with pemetrexed minimum of four courses 3. A measurable lesion is not required 4. Normal laboratory values 5. Signed informed consent 6. Thalidomide therapy to start within nine weeks after last chemotherapy course
Key exclusion criteria	1. Inaqdequate measures for birth control 2. Polyneuropathy more than grade one 3. Thrombo-embolic events
Date of first enrolment	09/09/2004
Date of final enrolment	01/01/2008

The Netherlands Cancer Center

Amsterdam
1066 CX
Netherlands

Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose (NVALT) (The Netherlands)
Research organisation

Luijbenstraat 15
Den Bosch
5211 BR
Netherlands

Industry

Eli Lilly (The Netherlands)

No information available

Thalidomide is prepared by Professor J Beijnen, pharmacist, The Slotervaart Hospital (The Netherlands)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2013		Yes	No