History of Changes for Study: 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

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Study Record Versions

Version	Submitted Date	Changes
1	April 26, 2022	None (earliest Version on record)
2	May 2, 2022	Study Status and Contacts/Locations
3	May 2, 2023	Study Status
4	December 6, 2023	Study Status and Eligibility

Comparison Format:

Merged
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Study Identification


Unique Protocol ID:	22-098
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
Official Title:	Phase II Study of Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Patients With Pleural Metastases From Thymic Malignancies
Secondary IDs:

Study Status


Record Verification:	May 2022
Overall Status:	Recruiting
Study Start:	April 26, 2022
Primary Completion:	April 2026 [Anticipated]
Study Completion:	April 2026 [Anticipated]

First Submitted:	April 26, 2022
First Submitted that Met QC Criteria:	April 26, 2022
First Posted:	April 29, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	May 2, 2022
Last Update Posted:	May 3, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Memorial Sloan Kettering Cancer Center
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring:

Study Description


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.
Detailed Description:

Conditions


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

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Single Group Assignment
	This is a single-arm Phase II single institution trial.
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	36 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) 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) 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.

Outcome Measures


Primary Outcome Measures:
1.	assess the rate of radiation pneumonitis [ Time Frame: 2 years ] as indicated by the rate of grade 3 or higher radiation pneumonitis defined by the NCI Common Terminology Criteria (CTC) version 5.0.
Secondary Outcome Measures:
1.	progression-free survival (PFS) [ Time Frame: 12 month ] 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.

Eligibility


Minimum Age:	18 Years
Maximum Age:	79 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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 History of myasthenia gravis as these patients may be at increased risk for pneumonitis 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/Locations


Central Contact Person:	Annemarie Shepherd, MD Telephone: 908-542-3430 Email: shephera@mskcc.org
Central Contact Backup:	Andreas Rimner, MD Telephone: 646-608-2449
Study Officials:	Annemarie Shepherd, MD Principal Investigator Memorial Sloan Kettering Cancer Center
Locations:	United States, New Jersey
	Memorial Sloan Kettering Basking Ridge (Limited protocol activities) [Recruiting] Basking Ridge, New Jersey, United States, 07920 Contact:Contact: Annemarie Shepherd, MD 908-542-3430
	Memorial Sloan Kettering Monmouth (Limited protocol activities) [Recruiting] Middletown, New Jersey, United States, 07748 Contact:Contact: Annemarie Shepherd, MD 908-542-3430
	Memorial Sloan Kettering Bergen (Limited protocol activities) [Recruiting] Montvale, New Jersey, United States, 07645 Contact:Contact: Annemarie Shepherd, MD 908-542-3430
	United States, New York
	Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities) [Recruiting] Commack, New York, United States, 11725 Contact:Contact: Annemarie Shepherd, MD 908-542-3430
	Memorial Sloan Kettering Westchester (Limited protocol activities) [Recruiting] Harrison, New York, United States, 10604 Contact:Contact: Annemarie Shepherd, MD 908-542-3430
	Memorial Sloan Kettering Cancer Center [Recruiting] New York, New York, United States, 10065 Contact:Contact: Annemarie Shepherd, MD 908-542-3430
	Memorial Sloan Kettering Nassau (Limited protocol activities) [Recruiting] Rockville Centre, New York, United States, 11553 Contact:Contact: Annemarie Shepherd, MD 908-542-3430

IPDSharing


Plan to Share IPD:	Yes Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL:

References


Citations:
Links:	URL: http://www.mskcc.org/mskcc/html/44.cfm Description: Memorial Sloan Kettering Cancer Center
Available IPD/Information: