Condition category
Cancer
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
03/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Storm

ORCID ID

Contact details

The Netherlands Cancer Center
NVALT Trial Desk
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

NVALT5

Study hypothesis

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

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).

Study design

Randomised, controlled, factorial, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Thalidomide

Primary outcome measures

Increase of five to 7.5 months for time to recurrence.

Secondary outcome measures

Toxicity (neurologic and thrombo-embolic).

Overall trial start date

09/09/2004

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

216

Participant exclusion criteria

1. Inaqdequate measures for birth control
2. Polyneuropathy more than grade one
3. Thrombo-embolic events

Recruitment start date

09/09/2004

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

The Netherlands Cancer Center
Amsterdam
1066 CX
Netherlands

Sponsor information

Organisation

Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose (NVALT) (The Netherlands)

Sponsor details

Luijbenstraat 15
Den Bosch
5211 BR
Netherlands
+31 (0)73 612 6163
secretariaat@nvalt.nl

Sponsor type

Research organisation

Website

http://www.nvalt.nl/

Funders

Funder type

Industry

Funder name

Eli Lilly (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Thalidomide is prepared by Professor J Beijnen, pharmacist, The Slotervaart Hospital (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23583604

Publication citations

  1. Results

    Buikhuisen WA, Burgers JA, Vincent AD, Korse CM, van Klaveren RJ, Schramel FM, Pavlakis N, Nowak AK, Custers FL, Schouwink JH, Gans SJ, Groen HJ, Strankinga WF, Baas P, Thalidomide versus active supportive care for maintenance in patients with malignant mesothelioma after first-line chemotherapy (NVALT 5): an open-label, multicentre, randomised phase 3 study., Lancet Oncol., 2013, 14, 6, 543-551, doi: 10.1016/S1470-2045(13)70125-6.

Additional files

Editorial Notes