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

Pleural Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05354570
• Other study ID #: 22-098
• Status: Recruiting
• Phase: Phase 2
• Start date: April 26, 2022
• Est. completion date: April 2026

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Annemarie Shepherd, MD
• Phone: 908-542-3430
• Email: shephera[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms
• Pleural Metastases

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited protocol activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited protocol activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited protocol activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited protocol activities)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression-free survival (PFS)	PFS events will include death and/or progression of thymic malignancy due to local-regional or distant recurrence/progression. PFS will be calculated from the start of radiation treatment and will be estimated by the Kaplan-Meier method.	12 month

External Links

•   Memorial Sloan Kettering Cancer Center