Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and general discomfort in patients with malignant pleural mesothelioma. It is not yet known if active symptom control is more effective with or without chemotherapy. PURPOSE: This randomized phase III trial is studying active symptom control and chemotherapy to see how well they work compared to active symptom control alone in treating patients with malignant pleural mesothelioma.

Detailed Description
-----------------
OBJECTIVES: Primary Compare the overall survival of patients with malignant pleural mesothelioma treated with active symptom control (ASC) alone vs ASC and mitomycin, vinblastine, and cisplatin vs ASC and vinorelbine. Secondary Compare the toxic effects of these regimens in these patients. Compare symptom palliation (chest pain, breathlessness, malaise, and sweating attacks) in patients treated with these regimens. Compare the performance status of patients treated with these regimens. Compare analgesic usage in patients treated with these regimens. Compare the tumor response and progression-free survival of patients treated with these regimens. Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive active symptom control (ASC) through regular visits at a specialist clinic. ASC may include steroids, analgesics, appetite stimulants, bronchodilators, and/or palliative radiotherapy, when required. Arm II: Patients receive ASC and chemotherapy comprising mitomycin IV, vincristine IV, and cisplatin IV on day 1. Chemotherapy repeats every 21 days for a total of 4 courses. Arm III: Patients receive ASC and vinorelbine IV over 5 minutes weekly for 6 weeks. Vinorelbine repeats every 55 days for a total of 2 courses. Quality of life is assessed at baseline, every 3 weeks for 21 weeks, and then every 8 weeks thereafter. Patients are followed at 15, 18, and 21 weeks, and then every 8 weeks thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 840 patients (280 per treatment arm) will be accrued for this study within 4 years.

Official Title
-----------------
A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma

Conditions
-----------------
Malignant Mesothelioma

Intervention / Treatment
-----------------
* Drug: cisplatin
* Drug: mitomycin C
* Drug: vincristine sulfate
* Drug: vinorelbine tartrate
* Procedure: pain therapy
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically and immunohistochemically confirmed malignant pleural mesothelioma Epithelial and other histological types are allowed No more than 3 months since diagnosis Symptomatic pleural effusion must have been treated and brought under control by drainage, pleurodesis, or pleurectomy Prior surgical resection of mesothelioma allowed provided 2 CT scans at least 6 weeks apart show stable or progressive disease PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic WBC > 3,000/mm^3 Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic Not specified Renal Creatinine clearance > 50 mL/min Pulmonary See Disease Characteristics Other Not pregnant or nursing Fertile patients must use effective contraception Considered medically fit to receive chemotherapy No other disease or prior malignancy likely to interfere with protocol treatments or comparisons No clinical evidence of infection PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for mesothelioma Endocrine therapy Not specified Radiotherapy Prior local radiotherapy to a wound site after exploratory thoracotomy allowed Surgery See Disease Characteristics See Radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: mitomycin C|nan|
|Drug: vincristine sulfate|nan|
|Drug: vinorelbine tartrate|nan|
|Procedure: pain therapy|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palliation of chest pain, breathlessness, malaise (e.g., feeling weak, tiredness, anorexia), and sweating attacks |  |  | 
| Performance status as measured by WHO grade |  |  | 
| Analgesic usage |  |  | 
| Toxicity as measured by the NCIC CTC |  |  | 
| Quality of life as assessed by the European Organization for Research and Treatment of Cancer |  |  | 
| Tumor response as measured by the RECIST criteria |  |  | 
| Progression-free survival as measured by CT scan |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epithelial mesothelioma, localized malignant mesothelioma, advanced malignant mesothelioma