Phase III trial of the anti-angiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy
| ISRCTN | ISRCTN13632914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13632914 |
| Protocol serial number | N/A |
| Sponsor | Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose (NVALT) (The Netherlands) |
| Funders | Eli Lilly (The Netherlands), Thalidomide is prepared by Professor J Beijnen, pharmacist, The Slotervaart Hospital (The Netherlands) |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 03/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr D Storm
Scientific
Scientific
The Netherlands Cancer Center
NVALT Trial Desk
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, factorial, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | NVALT5 |
| Study objectives | Maintenance thalidomide delays the time to progression with 50% in patients who do not progress after more than three cycles of pemetrexed containing chemotherapy. |
| Ethics approval(s) | 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). |
| Health condition(s) or problem(s) studied | Malignant mesothelioma |
| Intervention | Thalidomide 200 mg orally at night for up to one year with best supportive care or observation alone with best supportive care. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Thalidomide |
| Primary outcome measure(s) |
Increase of five to 7.5 months for time to recurrence. |
| Key secondary outcome measure(s) |
Toxicity (neurologic and thrombo-embolic). |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 216 |
| Key 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 |
| Key exclusion criteria | 1. Inaqdequate measures for birth control 2. Polyneuropathy more than grade one 3. Thrombo-embolic events |
| Date of first enrolment | 09/09/2004 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
The Netherlands Cancer Center
Amsterdam
1066 CX
Netherlands
1066 CX
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2013 | Yes | No |
