MATES: Maintenance Thalidomide in Mesothelioma Patients. A phase III trial of anti-angiogenic agent Thalidomide in patients with malignant pleural mesothelioma after first line chemotherapy.

Phase 3

Completed

• Conditions: nresectable malignant mesothelioma; Unresectable malignant mesothelioma; Cancer - Lung - Mesothelioma

• Registration Number: ACTRN12609000141246
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-06
• Study Completion: 2011-01-01
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Histologically or cytologically proven diagnosis of malignant mesothelioma of the pleura or peritoneum.
- Presence of at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > or = 20mm with conventional techniques or as > or = 10 mm with spiral computed tomography (CT) scan.
- Chemotherapy, containing the antifolate (pemetrexed), is required with at least stabilisation or response (Partial response (PR) or Complete Response (CR)) of the disease with a tleast 4 courses of therapy.
- Women of childbearing age must have a negative pregnancy test or must have adequate contraception during the study and for 3 months after cessation of thalidomide.
-Prior surgery or radiotherapy is allowed as long as there was evidence of progression.
- All cytotoxic therapies should be stopped at least 2 weeks before randomisation.
- Palliative radiotherapy to painful lesions or to prevent the development of metastases along biopsy tracks is allowed.
- Performance status according to Eastern Cooperative Oncology Group- World Health Organisation (ECOG WHO) < or = 2 (After palliative measures like pleural drainage)

Exclusion Criteria

-Pre-existing = grade II sensory neuropathy.
-Severe cardiac, pulmonary, metabolic or other serious co-morbid condiotions.
- Pregnant or lactating women are excluded.
- Life expectancy of < 3 months.
- Uncontrolled infections.
- Prior treatment with thalidomide.
- A period of > or = 6 weeks after the end of chemotherapy treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MAintenance Thalidomide in mEsothelioma patientS (MATES) alone: Quality of life using the Quality of life questionnaire C30 (QLQ-C30) and Quality of Life module LC13 (QLM-LC13), the Lung Cancer Symptom Scale (LCSS)- patient scale and the Pt DATA form completed by patients. The Spitzer Quality of Life Index (QLI) and the LCSS-observer scale completed by physicians.[ Statistical analysis of MATES study will be completed after recruitment and follow-up of 100 patients. During treatment and after treatment quality of life will be assessed every 4 weeks until disease progression.]