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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR798 |
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Date of registration:
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01/10/2006 |
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Primary sponsor: |
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Public title:
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Phase 3 trial of the antiangiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy.
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Scientific title:
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Phase 3 trial of the antiangiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy. - NVALT5 |
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Date of first enrolment:
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9/9/2004 |
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Target sample size:
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216 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=798 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Factorial; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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D.
Storm |
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Address:
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The Netherlands Cancer center
NVALT Trial Desk
Plesmanlaan 121
1066 CX
Amsterdam
The Netherlands |
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Telephone:
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+31(0)20 5129111 |
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Email:
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d.storm@nki.nl |
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Affiliation:
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Name:
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P.
Baas |
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Address:
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The Netherlands Cancer Insitute, Department of Pulmonology
Plesmanlaan 121
1066 CX
Amsterdam
The Netherlands |
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Telephone:
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+31(0)20 5122958 |
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Email:
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p.baas@nki.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Malignant mesothelioma
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Intervention(s)
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Thalidomide 200 mg orally at night for up to 1 year with best supportive care
or observation alone with best supportive care.
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Primary Outcome(s)
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Increase of 5 to 7.5 moths for time to recurrence.
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Secondary Outcome(s)
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Toxicity (neurologic and thrombo-embolic)
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Secondary ID(s)
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ISRCTN13632914
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N/A
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Source(s) of Monetary Support
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Eli Lilly Nederland B.V., Thalidomide is prepared by Prof J Beijnen farmacist, the Slotervaart hospital
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