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

NCT05354570 | Recruiting Phase 2 FDA Device

• 1 other identifier: 22-098
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 7

Brief Summary

The researchers are doing this study to find out whether hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) is a safe treatment that causes few or mild side effects in people with pleural metastases from thymic malignancies. The researchers will also look at whether hemithoracic IMPRINT is effective against participants' cancer.

Conditions

Thymic Malignancies; Pleural Metastases

Keywords

Intensity-Modulated Pleural Radiation Therapy (IMPRINT); 22-098

Outcome Measures

Primary Outcomes (1)

• assess the rate of radiation pneumonitis

  as indicated by the rate of grade 3 or higher radiation pneumonitis defined by the NCI Common Terminology Criteria (CTC) version 5.0.

  2 years

Secondary Outcomes (1)

• progression-free survival (PFS)

  12 month

Study Arms (1)

Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)

EXPERIMENTAL

Radiation will be administered over approximately 6 weeks to 50.4 Gy in 28 fractions with an optional SIB to gross residual disease.

Radiation: Intensity-Modulated Pleural Radiation Therapy (IMPRINT)

Interventions

Intensity-Modulated Pleural Radiation Therapy (IMPRINT) RADIATION

Radiation therapy will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions, including an optional dose-painting SIB to gross residual disease up to 60 Gy while respecting normal tissue constraints.

Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent to participate on the study
• Patients must have a pathologically confirmed diagnosis of thymic malignancy. Thymic carcinoma is allowed.
• Patients must have radiologic or pathologic evidence of pleural metastases. Patients may have de novo stage IVA or recurrent disease in the pleura. Gross disease in the fissure is allowed if resected.
• No evidence of extrathoracic metastatic disease or contralateral pleural/pericardial disease.
• Patient age ≥ 18 years but ≤ 80 years at the time of consent
• Karnofsky performance status ≥ 80%
• Preoperative or Postoperative Pulmonary Function Tests: DLCO \> 40% predicted (corrected for Hgb) and FEV1 ≥ 35% (corrected for Hgb)
• Glomerular filtration rate (GFR): ≥50 mL/min/1.73 m2 (must be calculated using estimated creatinine clearance (CrCl) by the Cockcroft-Gault (C-G) equation (Nephron 1976;16:31-41): CrCl (mL/min) = \[140 - age (years)\] x weight (kg) \[x 0.85 for female patients\] 72 x serum creatinine (mg / dL) ° 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.

You may not qualify if:

• Continuous oxygen use
• Patients with an acute flare of myasthenia gravis requiring addition of new medication in the past 6 months
• Prior nephrectomy on the contralateral side of the pleural metastases
• Prior thoracic radiation therapy preventing hemithoracic pleural IMRT. Prior thymic bed radiation is allowed. Prior pleural SBRT is allowed.
• Patients undergoing extrapleural pneumonectomy. Other surgical resection approaches of the pleural nodules (ex: P/D, debulking/metastasectomy) are allowed. Surgical resection of the primary thymic tumor is allowed.
• Acute congestive heart failure requiring hospitalization within the past 30 days.
• COPD requiring chronic oral steroid therapy of \> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are allowed
• Unstable angina requiring hospitalization and/or transmural myocardial infarction within the last 3 months
• History of interstitial lung disease
• Pregnant or lactating women
• Men or women not using effective contraception

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Charles Simone, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Simone, MD

CONTACT

212-639-3716; simonec1@mskcc.org

Andrew Pagano, MD

CONTACT

paganoa@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm Phase II single institution trial.

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: April 26, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (7)