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Phase 3 trial of the antiangiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy.


- candidate number2273
- NTR NumberNTR798
- ISRCTNISRCTN13632914
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR1-okt-2006
- Secondary IDsN/A 
- Public TitlePhase 3 trial of the antiangiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy.
- Scientific TitlePhase 3 trial of the antiangiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy.
- ACRONYMNVALT5
- hypothesisMaintenance thalidomide delays the time to progression with 50% in patients who do not progress after > 3 cycles of pemetrexed containing chemotherapy.
- Healt Condition(s) or Problem(s) studiedMalignant mesothelioma
- Inclusion criteria1. Good condition (PS 0-2);
2. First line therapy with pemetrexed minimum of 4 courses;
3. A measurable lesion is not required;
4. Normal laboratory values;
5. Signed informed consent;
6. Thalidomide therapy to start within 9 weeks after last chemotherapy course.
- Exclusion criteria1. Inaqdequate measures for birth control;
2. Polyneuropathy > grade 1;
3. Thrombo-embolic events.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupFactorial
- Type[default]
- Studytypeintervention
- planned startdate 9-sep-2004
- planned closingdate1-jan-2008
- Target number of participants216
- InterventionsThalidomide 200 mg orally at night for up to 1 year with best supportive care or observation alone with best supportive care.
- Primary outcomeIncrease of 5 to 7.5 moths for time to recurrence.
- Secondary outcomeToxicity (neurologic and thrombo-embolic)
- Timepoints
- Trial web siteNVALT website
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES D. Storm
- CONTACT for SCIENTIFIC QUERIESDr. P. Baas
- Sponsor/Initiator NVALT
- Funding
(Source(s) of Monetary or Material Support)
Eli Lilly Nederland B.V., Thalidomide is prepared by Prof J Beijnen farmacist, the Slotervaart hospital
- Publicationsonly on phase 2 study by P Baas et al 2005 Lung Cancer
- Brief summaryIn a phasee 2 study of patients with progressive mesothelioma, 27% showed stabilization of disease for more than 6 months. Therefore a phase 3 randomized study was developed to investigate the true gain of daily thalidomide in patients who have had no signs of progression of the disease after standard first line therapy. The hypothesis is that thalidomide is able to delay the revascularization of mesotheliomas. These are known for their high expression of VEGF and worse prognosis when a high vessel density is observed.
- Main changes (audit trail)
- RECORD1-okt-2006 - 19-aug-2013


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