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Recruiting NCT05354570

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

Phase II Interventional Thymic Malignancies Pleural Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intensity-Modulated Pleural Radiation Therapy (IMPRINT).
Who it may be relevant to
Registry conditions: Thymic Malignancies, Pleural Metastases. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
    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.

Primary outcome measures

  • assess the rate of radiation pneumonitis [Time frame: 2 years]
Secondary outcome measures (1)
  • progression-free survival (PFS) [Time frame: 12 month]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (Limited protocol activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre

Identifiers

NCT: NCT05354570 · 22-098

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗