New radiation method aims to reduce lung damage in mesothelioma patients
NCT ID NCT00715611
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study tests a new radiation technique called IMRT for people with malignant pleural mesothelioma, a rare lung cancer. The goal is to see if combining surgery, chemotherapy, and this targeted radiation is safe and reduces severe lung side effects. About 65 adults with early-stage disease are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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65 people
The number who actually took part.
- Start date
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Oct 2008
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. For all patients: DLCO \> 40% predicted (corrected for Hgb) 2. 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: 1. Absolute neutrophil count ≥1.5 K/mcL 2. Platelets ≥100 K/mcL 3. Serum total bilirubin ≤ 1.5 X ULN 4. AST (SGOT) or ALT (SGPT) ≤ 3.0 X ULN Note: patients enrolled after chemotherapy do not have to meet the above criteria Exclusion Criteria: * \> 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
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Md Anderson Cancer Center
Houston, Texas, 77030, United States
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Memoral Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk-Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering at Rockville Center, NY
Rockville Centre, New York, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Other studies related to the condition(s) this trial covers.
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