RECRUITING

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

Conditions

Thymic Malignancies Pleural Metastases Intensity-Modulated Pleural Radiation Therapy (IMPRINT)22-098

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-26

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05354570

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Charles Simone, MD

CONTACT

212-639-3716

simonec1@mskcc.org

Andrew Pagano, MD

CONTACT

paganoa@mskcc.org

Principal Investigator

Charles Simone, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Charles Simone, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-26

Study Completion Date2026-04

Study Record Updates

Study Start Date2022-04-26

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Thymic Malignancies
Pleural Metastases