| - candidate number | 2273 |
| - NTR Number | NTR798 |
| - ISRCTN | ISRCTN13632914 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 1-okt-2006 |
| - Secondary IDs | N/A |
| - Public Title | Phase 3 trial of the antiangiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy. |
| - Scientific Title | Phase 3 trial of the antiangiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy. |
| - ACRONYM | NVALT5 |
| - hypothesis | Maintenance 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) studied | Malignant mesothelioma |
| - Inclusion criteria | 1. 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 criteria | 1. Inaqdequate measures for birth control; 2. Polyneuropathy > grade 1; 3. Thrombo-embolic events. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Factorial |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 9-sep-2004 |
| - planned closingdate | 1-jan-2008 |
| - Target number of participants | 216 |
| - Interventions | Thalidomide 200 mg orally at night for up to 1 year with best supportive care or observation alone with best supportive care. |
| - Primary outcome | Increase of 5 to 7.5 moths for time to recurrence. |
| - Secondary outcome | Toxicity (neurologic and thrombo-embolic) |
| - Timepoints | |
| - Trial web site | NVALT website |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | D. Storm |
| - CONTACT for SCIENTIFIC QUERIES | Dr. 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 |
| - Publications | only on phase 2 study by P Baas et al 2005 Lung Cancer |
| - Brief summary | In 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) | |
| - RECORD | 1-okt-2006 - 31-dec-2006 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl