Actively Recruiting

Phase 2
Age: 18Years - 79Years
All Genders
ID05354570

Phase II Study of Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Patients With Pleural Metastases From Thymic Malignancies

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-06

36

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) to determine if it is a safe treatment option with minimal side effects for people with thymic malignancies that have spread to the lining of the lungs and chest. The study also aims to assess whether this radiation therapy is effective against cancer in these patients. This is a Phase II clinical trial sponsored by Memorial Sloan Kettering Cancer Center. Participants will receive radiation therapy over about 6 weeks, with a total dose of 50.4 Gy given in 28 sessions. There is an option for a higher dose to areas of visible remaining cancer while protecting normal tissues. This treatment targets the affected hemithoracic pleura, the lining of one side of the chest. During the study, participants will be monitored for side effects such as radiation pneumonitis over two years. Researchers will also measure progression-free survival at 12 months to see how well the cancer is controlled. Participants will have regular assessments including lung function tests and kidney function evaluations to ensure safety, with study participation lasting for at least two years of follow-up.

CONDITIONS

Brief Title

A Study of Intensity-Modulated Pleural Radiation Therapy (IMPRINT) in People With Thymic Cancer That Has Spread to the Lining of the Lungs and Chest

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent to participate on the study
  • Have a confirmed diagnosis of thymic malignancy or thymic carcinoma
  • Have radiologic or pathologic evidence of pleural metastases (stage IVA or recurrent disease)
  • No evidence of cancer outside the chest or on the opposite side pleura or pericardium
  • Be between 18 and 80 years old at consent
  • Have Karnofsky performance status of 80% or higher
  • Have lung function with DLCO greater than 40% predicted and FEV1 greater than or equal to 35% predicted
  • Have kidney function with glomerular filtration rate of 50 mL/min/1.73 m2 or higher calculated by Cockcroft-Gault equation
Not Eligible

You will not qualify if you...

  • Continuous oxygen use
  • Recent flare of myasthenia gravis needing new medication within 6 months
  • Prior removal of kidney on the opposite side of pleural metastases
  • Prior thoracic radiation that prevents hemithoracic pleural radiation therapy
  • Undergoing extrapleural pneumonectomy surgery
  • Acute congestive heart failure requiring hospitalization in past 30 days
  • COPD requiring chronic oral steroid therapy over 10 mg prednisone daily
  • Unstable angina or heart attack within last 3 months
  • History of interstitial lung disease
  • Pregnant or breastfeeding women
  • Men or women not using effective contraception

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 6 weeks

Participants receive intensity-modulated pleural radiation therapy (IMPRINT) over approximately 6 weeks to target pleural metastases from thymic malignancies.

28 radiation therapy sessions

Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

C

Charles Simone, MD

A

Andrew Pagano, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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