Status:
ACTIVE_NOT_RECRUITING
Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
M.D. Anderson Cancer Center
Princess Margaret Hospital, Canada
Conditions:
Mesothelioma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Provide written informed consent to participate on the study
- Patients must have a pathologically confirmed diagnosis either at MSKCC or at the participating site of stage I-III malignant pleural mesothelioma
- Epithelioid or biphasic histology subtype (Note: patients with biphasic histology can have \< 10% sarcomatoid)
- No evidence of metastatic disease.
- Patient age ≥ 18 years but ≤ 80 years at the time of consent.
- Karnofsky performance status ≥ 80%
- Pulmonary Function Tests:
- For all patients: DLCO \> 40% predicted (corrected for Hgb)
- For patients enrolled post-P/D, only: FEV1 \>/= 35% (corrected for Hgb) (Note: patients enrolled prior to P/D will have PFTs repeated pre-IMRT. If this criteria is not met, they will be removed from study)
- In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.
- Patient enrolled prior to chemotherapy must have adequate organ function as indicated by the following laboratory values:
- Absolute neutrophil count ≥1.5 K/mcL
- Platelets ≥100 K/mcL
- Serum total bilirubin ≤ 1.5 X ULN
- AST (SGOT) or ALT (SGPT) ≤ 3.0 X ULN Note: patients enrolled after chemotherapy do not have to meet the above criteria
Exclusion
- \> 10% Sarcomatoid or desmoplastic histology
- Continuous oxygen use
- Prior nephrectomy on the contralateral side of MPM
- Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of P/D (i.e.: intrapleural chemotherapy, photodynamic therapy, intrapleural betadine)
- Prior thoracic radiation therapy preventing hemithoracic pleural IMRT
- Bulky disease in the fissure preventing lung-sparing pleural IMRT
- Patients undergoing extrapleural pneumonectomy
- Patients with an active infection that require systemic antibiotics, antiviral, or antifungal treatments
- Patients with a concurrent active malignancy (except squamous or basal cell carcinoma of the skin)
- Patients with serious unstable medical illness
- Presence of third space fluid that cannot be controlled by drainage
- For patients who develop or have baseline clinically significant pleural effusions before or during initiation of pemetrexed therapy; consideration should be given to drain the effusion prior to chemotherapy administration
- No acute congestive heart failure
- Pregnant or lactating women
- Men or women not using effective contraception
- Reproductive risks Patients should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breast-feed a baby while on this study. Women of childbearing age will be counseled to use birth control while on this study.
Key Trial Info
Start Date :
October 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00715611
Start Date
October 11 2008
End Date
July 1 2026
Last Update
August 15 2025
Active Locations (12)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
4
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920