A Feasibility Study Evaluating Neoadjuvant Hemithoracic Intensity Modulated Radiation Therapy for Surgically Resectable Malignant Pleural Mesothelioma
The study is a phase I/II prospective single cohort clinical feasibility study. 25 patients
with early stage resectable malignant pleural mesothelioma will be enrolled into the study.
Patients will have a baseline PET scan. Patients on the study will receive IMRT for
approximately 1 week of 5 daily treatments. 1 week post-RT, they will proceed with an
extrapleural pneumonectomy. If the mediastinal lymph nodes that are removed during surgery
are positive for tumour cells, 3 cycles of chemotherapy, consisting of raltitrexed and
cisplatin OR Pemetrexed and cisplatin, will be given 6-12 weeks post-surgery. Before and
during treatment, side effects will be assessed. After treatment, follow up visits will be
conducted every 1 to 2 months for the first year, and every 3 months for the second year.
At each visit, a history and physical examination will be performed and ECOG performance
status will be assessed. Routine tests will include CBC, liver profile, creatinine and
chest x-ray. CT thorax and abdomen will be done at 3, 6, 12, 18, and 24 months. Additional
test may be done at the discretion of the oncologist if the patient becomes symptomatic.
The study will evaluate the feasibility and safety of short pre-operative RT, and may help
confirm the intraoperative seeding hypothesis. Preoperative RT may also reduce the risk of
both local and distant spread and, ultimately, improve overall survival. By shortening
overall treatment time, it may also improve patient compliance and convenience. We may be
able to give chemotherapy only to patients that are at highest risk and avoid it in others.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary outcome for the study will be the proportion of patients treated as per protocol without treatment related mortality.
After completion of therapy: every 4 wks for 3 mos, then every 6 wks for 6 mos, then every 2 mos for 12 mos, then every 3 mos for 2 yrs, then every 6 mos for 5 years
John Cho, MD
University Health Network, Toronto
Canada: Ethics Review Committee
UHN REB 08-0106-C