Malignant Pleural Mesothelioma Clinical Trial
Official title:
EORTC Randomized Phase II Study of Pleurectomy/ Decortication (P/D) Preceded or Followed by Chemotherapy in Patients With Early Stage Malignant Pleural Mesothelioma
This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage MPM will be randomized between Arm A: immediate P/D followed by three cycles of chemotherapy (pemetrexed 500mg/m2 and cisplatin 75 mg/m2, both drugs given on day 1, every three weeks) Arm B: three cycles of chemotherapy (same regimen) followed by P/D, for non-progressing patients
This is an academic led, multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage MPM will be randomized between - Arm A - immediate surgery: immediate P/D followed by three cycles of chemotherapy (pemetrexed 500mg/m2 and cisplatin 75 mg/m2, both drugs given on day 1, every three weeks) for non-progressing patients - Arm B - delayed surgery: three cycles of chemotherapy (same regimen) followed by P/D, for non-progressing patients. A maximum of four weeks (±2 weeks) will be allowed between the baseline tumor assessment and the start of treatment (surgery or chemotherapy). Randomization should be done as soon as possible after baseline tumor assessment. The primary objective of the study is to investigate the feasibility of immediate P/D followed by cisplatin/pemetrexed chemotherapy or deferred P/D after cisplatin/pemetrexed chemotherapy in patients with early stage MPM. The results of this study will allow the LCG to take one of the arms further to a comparative study with either no surgery or EPP as control arm. The choice of the comparator will depend on the result of a parallel ongoing randomized study in the UK, comparing P/D with no surgery ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06037941 -
Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma
|
N/A | |
Completed |
NCT01675765 -
Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma
|
Phase 1 | |
Withdrawn |
NCT04201145 -
Pembrolizumab + Defactinib In Pleural Mesothelioma
|
Phase 1 | |
Completed |
NCT03048474 -
Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma
|
Phase 2 | |
Completed |
NCT02369198 -
MesomiR 1: A Phase I Study of TargomiRs as 2nd or 3rd Line Treatment for Patients With Recurrent MPM and NSCLC
|
Phase 1 | |
Terminated |
NCT01870609 -
Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma
|
Phase 2 | |
Active, not recruiting |
NCT00886028 -
Palliative Treatment With Liposomal Doxorubicin Plus Cisplatin for Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
Completed |
NCT00272558 -
Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma
|
Phase 2 | |
Completed |
NCT04843007 -
Alvopem® (Pemetrexed) Safety Assessment
|
||
Completed |
NCT01721018 -
Intrapleural Administration of HSV1716 to Treat Patients With Malignant Pleural Mesothelioma.
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00797719 -
Short Neoadjuvant Hemithoracic IMRT for MPM
|
Phase 1/Phase 2 | |
Completed |
NCT00386815 -
Safety Confirmation Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
|
Phase 2 | |
Recruiting |
NCT03715933 -
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
|
Phase 1 | |
Completed |
NCT04775446 -
Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy
|
||
Completed |
NCT01644994 -
Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma
|
Phase 1/Phase 2 | |
Completed |
NCT01865045 -
Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients
|
||
Completed |
NCT00571298 -
Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma
|
Phase 1 | |
Recruiting |
NCT01343264 -
Trimodality Therapy for Malignant Pleural Mesothelioma
|
N/A | |
Active, not recruiting |
NCT04162015 -
A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma
|
Phase 1 | |
Recruiting |
NCT04400539 -
The IMmunotherapy Pleural 5-ALA PDT
|
Phase 2 |