Malignant Mesothelioma Clinical Trial
Official title:
A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06057935 -
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
|
Phase 2 | |
Completed |
NCT00821860 -
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
|
Phase 3 | |
Completed |
NCT00004033 -
Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
Active, not recruiting |
NCT03678350 -
Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery
|
Phase 1 | |
Recruiting |
NCT02580747 -
Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
|
Phase 1 | |
Completed |
NCT00398138 -
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
|
Phase 1 | |
Completed |
NCT00019825 -
Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura
|
Phase 1 | |
Terminated |
NCT00898547 -
Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107
|
||
Active, not recruiting |
NCT00030459 -
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
Completed |
NCT00004183 -
Capecitabine in Treating Patients With Malignant Mesothelioma
|
Phase 2 | |
Completed |
NCT00004254 -
Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
|
Phase 2 | |
Completed |
NCT00005636 -
Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
|
Phase 3 | |
Completed |
NCT00004920 -
Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
|
Phase 3 | |
Completed |
NCT00334594 -
Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
Completed |
NCT01291420 -
Dendritic Cell Vaccination for Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03852823 -
Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours
|
Phase 1 | |
Active, not recruiting |
NCT01649024 -
A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
|
Phase 2 | |
Completed |
NCT00372840 -
Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer
|
N/A | |
Completed |
NCT00513877 -
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
Active, not recruiting |
NCT00253409 -
Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery
|
N/A |