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Phase III trial of the anti-angiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy
DOI 10.1186/ISRCTN13632914
ClinicalTrials.gov identifier
EudraCT number
Public title Phase III trial of the anti-angiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy
Scientific title
Acronym NVALT5
Serial number at source N/A
Study hypothesis Maintenance thalidomide delays the time to progression with 50% in patients who do not progress after more than three cycles of pemetrexed containing chemotherapy.
Lay summary Not provided at time of registration
Ethics approval 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).
Study design Randomised, controlled, factorial, multicentre trial
Countries of recruitment Netherlands
Disease/condition/study domain Malignant mesothelioma
Participants - 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
Participants - exclusion criteria 1. Inaqdequate measures for birth control
2. Polyneuropathy more than grade one
3. Thrombo-embolic events
Anticipated start date 09/09/2004
Anticipated end date 01/01/2008
Status of trial Completed
Patient information material
Target number of participants 216
Interventions Thalidomide 200 mg orally at night for up to one year with best supportive care or observation alone with best supportive care.
Primary outcome measure(s) Increase of five to 7.5 months for time to recurrence.
Secondary outcome measure(s) Toxicity (neurologic and thrombo-embolic).
Sources of funding 1. Eli Lilly (The Netherlands)
2. Thalidomide is prepared by Professor J Beijnen, pharmacist, The Slotervaart Hospital (The Netherlands)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23583604
Contact name Dr  D  Storm
  Address The Netherlands Cancer Center
NVALT Trial Desk
Plesmanlaan 121
  City/town Amsterdam
  Zip/Postcode 1066 CX
  Country Netherlands
Sponsor Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose (NVALT) (The Netherlands)
  Address Luijbenstraat 15
  City/town Den Bosch
  Zip/Postcode 5211 BR
  Country Netherlands
  Tel +31 (0)73 612 6163
  Fax +31 (0)73 612 6154
  Email secretariaat@nvalt.nl
  Sponsor website: http://www.nvalt.nl/
Date applied 28/12/2006
Last edited 03/07/2013
Date ISRCTN assigned 28/12/2006
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