Pre-op Radiation Therapy for Mesothelioma

Recruiting in Palo Alto (17 mi)

Overseen byJohn Cho, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University Health Network, Toronto

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?Malignant pleural mesotheliomas (MPMs) are tumours associated with asbestos exposure involving the tissue lining surrounding the lung. Radiation therapy (RT) dramatically reduces the risk of tumour recurrence within the irradiated area (\>90%). But patients continue to succumb to MPMs due to the tumour spreading outside the chest cavity. This may be due to tumour cells inadvertently contaminating areas outside the chest cavity during surgery. The study will look at whether giving a short intense course of chest radiation just prior to surgery will sterilized these tumour cells and thus, avoid or reduce contamination of the areas outside the chest cavity. The investigators hypothesize that short neoadjuvant (pre-operative) hemithoracic RT, followed by immediate planned extrapleural pneumonectomy (EPP) (+/- adjuvant chemotherapy) will reduce the risk of intra-operative seeding and reduce the incidence of distant metastatic disease.

Eligibility Criteria

This trial is for adults with a new diagnosis of Malignant Pleural Mesothelioma (MPM) who are in good health otherwise, have not had previous chemotherapy or thoracic radiation, and are not pregnant. They should be able to undergo surgery and have an ECOG performance status of 0-2.

Inclusion Criteria

ECOG performance status of 0-2

Good pulmonary function precluding radiation therapy (FEV>1 L or >40% predicted or DLCO >45% predicted)

Any patient with a new histological diagnosis of malignancy pleural mesothelioma (MPM). Sarcomatoid or biphasic histologies can be included but will be analyzed separately due to their poor prognosis

+3 more

Exclusion Criteria

Distant metastatic disease

You have received chemotherapy for this or another cancer at the same time.

Women who are currently pregnant or lactating

+3 more

Participant Groups

The study tests if short intense chest radiation before surgery can prevent the spread of tumor cells during the operation. It's followed by extrapleural pneumonectomy (EPP), which may include additional chemotherapy after surgery.

1Treatment groups

Experimental Treatment

Group I: AllExperimental Treatment1 Intervention

This is a single arm study. All patients enrolled will be in this arm.