Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00075699|
Recruitment Status : Completed
First Posted : January 13, 2004
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: cisplatin Drug: mitomycin C Drug: vincristine sulfate Drug: vinorelbine tartrate Procedure: pain therapy Procedure: psychosocial assessment and care Procedure: quality-of-life assessment||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||840 participants|
|Official Title:||A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma|
|Study Start Date :||September 2003|
- Overall survival
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075699
|Leeds General Infirmary at Leeds Teaching Hospital NHS Trust|
|Leeds, England, United Kingdom, LS1 3EX|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Principal Investigator:||Martin F. Muers, MD||Leeds General Infirmary|