Study on Surgery, Chemotherapy, and Targeted Radiation for Locally Advanced Malignant Pleural Mesothelioma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT00715611
This clinical trial is testing a new approach that combines surgery, chemotherapy, and a special type of radiation therapy to treat patients with locally advanced malignant pleural mesothelioma, a type of cancer affecting the lining of the lungs.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to evaluate the safety and effectiveness of combining surgery, chemotherapy, and a new radiation technique called Intensity Modulated Radiation Therapy (IMRT) for treating malignant pleural mesothelioma. This type of cancer affects the lining of the lungs, and the standard treatment usually involves chemotherapy. Radiation therapy is not typically used because it can cause severe side effects, including lung damage. However, IMRT is designed to target the cancer more precisely, reducing the risk of harming the lung itself. Participants will undergo surgery to remove the cancerous lining, followed by chemotherapy and IMRT to the pleura, the lining of the lung.
Eligibility Criteria
Inclusion Criteria
- Agree to participate by signing a consent form.
- Diagnosed with stage I-III malignant pleural mesothelioma, confirmed by a medical center.
- Cancer type must be epithelioid or biphasic, with less than 10% sarcomatoid cells.
- No signs of cancer spreading to other parts of the body.
- Aged between 18 and 80 years.
- Good overall health with a performance status of 80% or higher.
- Lung function tests must show adequate breathing capacity.
- If there are concerns about kidney function, a special kidney scan may be done before radiation.
- Must have adequate blood cell counts and liver function before starting chemotherapy.
Exclusion Criteria
- Cancer type with more than 10% sarcomatoid cells.
- Need for continuous oxygen therapy.
- Previous removal of a kidney on the opposite side of the cancer.
- Previous treatments inside the chest cavity, except for pleurodesis.
- Previous chest radiation that prevents new radiation treatment.
- Large tumors in the lung fissure that prevent safe radiation.
- Undergoing a more extensive lung surgery called extrapleural pneumonectomy.
- Active infections requiring treatment.
- Another active cancer, except for certain skin cancers.
- Serious, unstable medical conditions.
- Fluid buildup that cannot be controlled by drainage.
- Significant fluid around the lungs before or during chemotherapy.
- Heart failure that is not controlled.
- Pregnant or breastfeeding women.
- Men and women not using effective birth control.
Reproductive risks: Participants should avoid pregnancy or fathering a child during the study, as the drugs used can harm an unborn baby. Women should not breastfeed while participating. Women of childbearing age will be advised to use birth control.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Mayo Clinic Cancer Center | 55905 | Rochester | Minnesota |
| Memorial Sloan Kettering at Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Cancer Center @ Suffolk-Commack | 11725 | Commack | New York |
| Memoral Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering at Rockville Center, NY | Rockville Centre | New York |
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