A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma
- Determine the feasibility of neoadjuvant chemotherapy comprising pemetrexed disodium
and cisplatin followed by extrapleural pneumonectomy and high-dose postoperative
3D-conformal radiotherapy, in terms of 90-day progression-free survival, in patients
with malignant pleural mesothelioma.
- Determine the toxicity of this regimen in these patients.
- Determine progression-free survival and overall survival of patients treated with this
OUTLINE: This is a non-randomized, multicenter study.
- Neoadjuvant chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes and
cisplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for up to 3 courses
in the absence of disease progression or unacceptable toxicity. Patients are evaluated
3 weeks after completion of neoadjuvant chemotherapy. Patients without disease
progression proceed to surgery.
- Extrapleural pneumonectomy: Within 21-56 days after completion of neoadjuvant
chemotherapy, patients undergo extrapleural pneumonectomy. Patients are evaluated 30
days after surgery. Patients without disease progression undergo high-dose 3D-conformal
- High-dose 3D-conformal radiotherapy: Beginning 30-84 days after surgery, patients
undergo high-dose 3D-conformal radiotherapy daily for 30 days.
After completion of study treatment, patients are followed on days 42 and 90, every 3 months
for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
Allocation: Non-Randomized, Primary Purpose: Treatment
Feasibility in terms of 90-day progression-free survival
Paul Van Schil, MD, PhD
Universitair Ziekenhuis Antwerpen
United States: Federal Government