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Phase II Toxicity Study of Pleurectomy/Decortication, (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma
For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and implementation of standard pleurectomy/decortication (removal of the surface lining of the lung) and standard chemotherapy followed by IMRT performed at other centers. Patients will undergo pleurectomy/decortication chemotherapy and hemithoracic pleural IMRT to the pleura in patients with malignant pleural mesothelioma.
Details
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 65 |
| Start date | 2008-10-11 |
| Completion | 2026-07 |
Conditions
- Mesothelioma
Interventions
- Pleurectomy/Decortication
- pemetrexed and cisplatin or carboplatin
- Intensity Modulated Radiation Therapy
Primary outcomes
- number of patients ≥ grade 3 pneumonitis — 2 years
Grade 3 pneumonitis is defined as symptomatic, interfering with ADL's and requiring oxygen support as defined by the NCI Common Terminology Criteria (CTC) version 4.0 for toxicity and Adverse Event reporting.
Countries
United States