Maintenance thalidomide delays the time to progression with 50% in patients who do not progress after > 3 cycles of pemetrexed containing chemotherapy.
ID
Bron
Verkorte titel
Aandoening
Stabilisation or response to first line chemotherapy including pemetrexed.
Patients randomized in the obeservation arm will only receive best supportive care
Ondersteuning
Thalidomide is prepared by Prof J Beijnen farmacist, the Slotervaart hospital
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Increase of 5 to 7.5 moths for time to recurrence.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Maintenance thalidomide delays the time to progression with 50% in patients who do not progress after > 3 cycles of pemetrexed containing chemotherapy.
Onderzoeksproduct en/of interventie
Thalidomide 200 mg orally at night for up to 1 year with best supportive care
or observation alone with best supportive care.
Publiek
NVALT Trial Desk
Plesmanlaan 121
D. Storm
Amsterdam 1066 CX
The Netherlands
+31(0)20 5129111
d.storm@nki.nl
Wetenschappelijk
NVALT Trial Desk
Plesmanlaan 121
D. Storm
Amsterdam 1066 CX
The Netherlands
+31(0)20 5129111
d.storm@nki.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Inaqdequate measures for birth control;
2. Polyneuropathy > grade 1;
3. Thrombo-embolic events.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL786 |
| NTR-old | NTR798 |
| Ander register | : N/A |
| ISRCTN | ISRCTN13632914 |