NCT00715611Active, not recruitingPhase 2
Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma
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
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 11 Jul 2008
- Start date
- 11 Oct 2008
- Primary completion date
- Jul 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Mesothelioma
- NCT number
- NCT00715611
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 65
- From 11 Oct 2008 to the primary completion date, Jul 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients with a concurrent active malignancy (except squamous or basal cell carcinoma of the skin)
- 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
Other illness
- Bulky disease in the fissure preventing lung-sparing pleural IMRT
- Patients with an active infection that require systemic antibiotics, antiviral, or antifungal treatments
- Patients with serious unstable medical illness
- No acute congestive heart failure
Age
- 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.
Other
- \> 10% Sarcomatoid or desmoplastic histology
- Continuous oxygen use
- Patients undergoing extrapleural pneumonectomy
- Presence of third space fluid that cannot be controlled by drainage
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center @ Suffolk - Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memoral Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic Cancer Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Memorial Sloan Kettering at Rockville Center, NY Coordinator of this site? Confirm its status | Rockville Centre | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.