Status:
ACTIVE_NOT_RECRUITING
Short Neoadjuvant Hemithoracic IMRT for MPM
Lead Sponsor:
University Health Network, Toronto
Conditions:
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 re...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- ECOG performance status of 0-2
- Good pulmonary function precluding radiation therapy (FEV\>1 L or \>40% predicted or DLCO \>45% predicted)
- Any patient wiht 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
- Stage T1-2N0M0 based on conventional investigations and tests. Selected stage T3N0M0 may be included at the discretion of the surgeon if deemed resectable.
- Suitable for combined modality therapy
- Informed consent
Exclusion
- Distant metastatic disease
- Previous thoracic irradiation
- Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment
- Previous chemotherapy for this or concurrent malignancy
- Previous concomitant malignancies except for patients with non-melanoma skin cancer, contralateral non-invasive breast cancer, prostate cancer treated with curative intent or carcinoma in situ of any other site. In addition, patients with invasive cancers treated more than 3 years previously and without evidence of recurrence will be eligible
- Women who are currently pregnant or lactating
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00797719
Start Date
October 1 2008
End Date
September 1 2027
Last Update
February 20 2025
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2M9