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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
083522
ACTR Number:
ACTRN12609000141246
Trial Status:
Registered
Date Submitted:
2/03/2009
Date Registered:
6/03/2009
Page 1
Public title:
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.
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ANZCTR registration title:
MATES: A phase III trial of anti-angiogenic agent Thalidomide in patients with unresectable malignant mesothelioma who are not progressing after first line therapy compared to no additional treatment after chemotherapy to assess the effectiveness of Thalidomide using time to progression.
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Secondary ID:
UTN:
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Trial acronym:
MATES
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Page 2
Health condition(s) or problem(s) studied:
Unresectable malignant mesothelioma
Condition category:
Condition code:
Cancer
Lung - Mesothelioma
Page 3
Description of intervention(s) / exposure:
Addition of Thalidomide 6 weeks after the end of first line chemotherapy, involving antifolate (pemetrexed) with or with out platinum combination (4-6 Cycles). Thalidomide will be administered daily until disease progression or a maximim of 1 year. Patients randomised to receive thalidomide will be treated with thalidomide 100 mg (Starting dose) nightly for the first two weeks. If there are no severe side effects the dose will be increased to 200mg nightly. The mode of administration is oral.
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Intervention code:
Treatment: drugs
Comparator / control treatment:
First line chemotherapy only (Duration is not mentioned here as it will vary based on the treating doctors discretion, involving antifolate (pemetrexed) with or with out platinum combination (4-6 cycles). The first line chemotherapy regimen (i.e. dose and platinum drugs) is up to the health profession's discretion.
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Control group:
Active
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Page 4
Primary outcome:
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.
Timepoint:
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.
Secondary outcome 1:
Pooled NVALT5/ MATES (The main objective of NVALT 5 study is to evaluate the effect of maintenance by thalidomide in the time to progression (TTP) in patients who did not progress after > or = 4 courses of treatment and pemetrexed +/- platinum. All time dependent end-points will be taken from the date of randomisation. The main objective of MATES is QOL, and TTP is a secondary endpoint. The data from MATES on TTP, progression free survival and toxicity will be pooled with the NVALT-5 study in a prospective meta-analysis of these endpoints): Time to progression will be assessed with CT scans, chest X-rays and other disease evaluation tools.
Timepoint:
From randomisation until the first observation of disease progression, every 8 weeks.
Secondary outcome 2:
Progression free survival will also be assessed with CT scans, chest X-rays and other disease evaluation tools.
Timepoint:
From randomisation until first observation of disease progression, every 8 weeks or death from any cause.
Secondary outcome 3:
Toxicity will be assessed by clinical and laboratory adverse events using Common Toxicity Criteria version 3
Timepoint:
Toxicity is assessed weekly for first four weeks during treatment and then at the end of cycle every 4 weeks until the end of treatment.
Secondary outcome 4:
Prognostic value of biomarkers will be assessed by using survival and volumetric tumour burden.
Timepoint:
Assessed at the end of cycle every 4 weeks until week 16. Statistical analysis of pooled NVALT5/MATES study will be completed after recruitment and follow-up of 216 patients. All patients during treatment will have a clinical exam, clinical symptoms/toxicity evaluation and blood analysis every 4 weeks and radiology tests every 8 weeks, after treatment all patients will have 8 weekly radiological tests (CT scans, X-rays) until disease progression.
Page 5
Key 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)
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Minimum Age:
18
Years
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Maximum Age:
No limit
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Gender:
Both males and females
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Healthy volunteers?
No
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Key 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.
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Page 6
Study type:
Interventional
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Purpose of the study:
Treatment
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Allocation to intervention:
Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Enrolment and randomisation will be performed centrally by computer.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Simple randomisation by using a randomization table created by a computer sofware.
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Masking / blinding:
Open (masking not used)
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Assignment:
Parallel
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Other design features (specify):
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Type of endpoint(s):
Efficacy
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Page 7
Phase
Phase 3
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Anticipated or actual date of first participant enrolement:
1/02/2009
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Target sample size:
100
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Recruitment status:
Open to recruitment
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Page 8
Funding source:
Government funding body e.g. Australian Research Council
Name:
National Health and Medical Research Council
Address:
National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601
Country:
Australia
Primary sponsor:
University
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Reason:
Name:
University of Sydney
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Address:
6-10 Mallett Street Camperdown NSW-2050
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Country:
Australia
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Secondary sponsor:
None
Name:
Address:
Country:
Other collaborator:
Other Collaborative groups
Name:
Dutch Association of Physicians for Pulmonary Diseases (NVALT) Group
Address:
NKI-AVL POSTBUS 90203 1006 BE Amsterdam The Netherlands
Country:
Netherlands
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name:
NSW Cancer Institute Ethics Committee
Address:
PO Box 41 Alexandria NSW 1435
Country:
Australia
Date of approval:
28/07/2008
HREC Number:
2008C/04/050
Countries of recruitment:
Australia
Postcode:
2340, 2050, 2450, 2750, 2031, 2350, 2300, 4032, 4560, 4102, 4020
2000, 2009
Brief summary:
Malignant pleural mesothelioma is a tumour in the lining outside of the lung. This type of tumour is closely linked to exposure to asbestos fibres. The purpose of this study is to determine if treatment with thalidomide for people with malignant pleural mesothelioma will delay the time until the disease gets worse and also if it will keep people feeling better.
Thalidomide was originally used as a sedative during pregnancy in the late 1950s, with detrimental effects on the embryo. However since then, it has been found that thalidomide may delay tumour growth in people with mesothelioma. The formation of new blood vessels (angiogenesis), plays an important role in tumour growth and spread. Thalidomide stops or delays the formation of new blood vessels (anti-angiogenic effect), which may prevent or slow down the return of cancer.
The research is being done because it is not clear if treatment with thalidomide after treatment with pemetrexed can offer better results than the usual care, which is to have no further chemotherapy treatment after treatment with pemetrexed.
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Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Brooke Wilson
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Address:
National Health and Medical Research Centre (NHMRC) Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown NSW 1450
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Country:
Australia
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Tel:
+61 2 9562 5321
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Fax:
+61 2 9562 5094
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Email:
mates@ctc.usyd.edu.au
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Contact person for scientific queries
Name:
Nick Pavlakis
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Address:
Royal North Shore Hospital, Pacific Highway St Leonards, NSW- 2065
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Country:
Australia
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Tel:
+61 2 9926 5020
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Fax:
+61 2 9438 2604
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Reason:
Email:
pavlakis@med.usyd.edu.au
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Reason:
Contact person responsible for updating information
Name:
Brooke Wilson
Update:
Reason:
Address:
National Health and Medical Research Centre (NHMRC) Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown NSW 1450
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Reason:
Country:
Australia
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Reason:
Tel:
+61 2 9562 5321
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Fax:
+61 2 9562 5094
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Email:
brooke.wilson@ctc.usyd.edu.au
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