New radiation method aims to reduce lung damage in mesothelioma patients

NCT ID NCT00715611

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

65 people

The number who actually took part.

Start date

Oct 2008

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905, United States

  • Md Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Memoral Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering at Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering at Rockville Center, NY

    Rockville Centre, New York, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

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