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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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering at Basking Ridge
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Basking RidgeUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack
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CommackUnited StatesUnknown status
Memoral Sloan Kettering Westchester
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HarrisonUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Memorial Sloan Kettering Monmouth
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MiddletownUnited StatesUnknown status
Memorial Sloan Kettering Bergen
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MontvaleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Mayo Clinic Cancer Center
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RochesterUnited StatesUnknown status
Memorial Sloan Kettering at Rockville Center, NY
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Rockville CentreUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Memorial Sloan Kettering Nassau
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UniondaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.