Short Neoadjuvant Hemithoracic IMRT for MPM

Titre officiel

A Feasibility Study Evaluating Neoadjuvant Hemithoracic Intensity Modulated Radiation Therapy for Surgically Resectable Malignant Pleural Mesothelioma

Sommaire:

Le mésothéliome pleural malin (MPM) est une tumeur associée à l’exposition à l’amiante  qui se forme dans la membrane entourant le poumon. La radiothérapie réduit considérablement le risque de récidive tumorale dans la région irradiée (> 90 %). Cependant, des patients succombent toujours à la maladie à cause de la propagation de leur tumeur à l’extérieur de la cavité thoracique. La propagation pourrait être due à la contamination involontaire de zones à l’extérieur de la cavité thoracique par les cellules tumorales durant la chirurgie. L’étude vise à déterminer si l’administration d’une radiothérapie thoracique à fortes doses et de courte durée juste avant la chirurgie permet de stériliser ces cellules tumorales et, par conséquent, d’éviter ou de réduire la contamination des zones à l’extérieur de la cavité thoracique. Les chercheurs avancent l’hypothèse que de courtes séances de radiothérapie hémithoracique néoadjuvante (pré-opératoire), suivies immédiatement d’une pneumonectomie extrapleurale (avec ou sans chimiothérapie adjuvante), réduiront le risque d’essaimage des cellules tumorales durant l’opération ainsi que la fréquence des métastates à distance.

Description de l'essai

Primary Outcome:

• The primary outcome for the study will be the proportion of patients treated as per protocol without treatment related mortality.

Secondary Outcome:

• To evaluate: acute and late morbidity related to treatment; local & distant recurrence, disease free & overall survival; identify factors/parameters associated with increased risk of treatment morbidity

The study is a phase I/II prospective single cohort clinical feasibility study. 100 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.

Voir cet essai sur ClinicalTrials.gov