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Radiation

IMPRINT Radiation Therapy for Thymic Cancer

Phase 2
Recruiting
Led By Charles Simone, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a pathologically confirmed diagnosis of thymic malignancy. Thymic carcinoma is allowed.
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.
Must not have
Men or women not using effective contraception
Prior nephrectomy on the contralateral side of the pleural metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether a radiation therapy called hemithoracic IMPRINT is safe and effective in treating people with pleural metastases from thymic malignancies.

Who is the study for?
This trial is for adults aged 18-80 with thymic cancer that has spread to the lung and chest lining but not beyond. Participants must be in good physical condition, have a certain level of lung and kidney function, and cannot be pregnant or breastfeeding. They must agree to use contraception and have no history of severe lung disease, recent heart failure, or specific treatments like thoracic radiation.
What is being tested?
The study is testing Intensity-Modulated Pleural Radiation Therapy (IMPRINT) specifically for patients with pleural metastases from thymic malignancies. It aims to determine the safety profile of IMPRINT and its effectiveness in controlling cancer spread within the chest area.
What are the potential side effects?
While side effects are expected to be few or mild, potential risks may include damage to surrounding organs such as lungs and kidneys due to radiation exposure, fatigue, skin reactions at the treatment site, shortness of breath, coughing up blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed to be thymic malignancy or thymic carcinoma.
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My kidney function is good enough for the treatment.
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I am between 18 and 80 years old.
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My cancer has not spread outside my chest or to the opposite side of my chest.
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My lung function tests show I have more than 40% of the expected capacity.
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My cancer has not spread outside my chest or to the opposite side of my chest.
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My cancer is confirmed to be thymic malignancy or thymic carcinoma.
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I can carry out normal activities with minimal symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not using any form of birth control.
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I had a kidney removed on the opposite side of my chest cancer spread.
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I haven't had a severe heart attack or unstable angina in the last 3 months.
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I have a history of lung scarring or fibrosis.
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I use oxygen all the time.
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I have a history of myasthenia gravis.
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I take more than 10 mg of prednisone daily for my COPD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
assess the rate of radiation pneumonitis
Secondary study objectives
progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)Experimental Treatment1 Intervention
Radiation will be administered over approximately 6 weeks to 50.4 Gy in 28 fractions with an optional SIB to gross residual disease.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,807 Total Patients Enrolled
Charles Simone, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
229 Total Patients Enrolled
Annemarie Shepherd, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
130 Total Patients Enrolled

Media Library

Intensity-Modulated Pleural Radiation Therapy (IMPRINT) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05354570 — Phase 2
Pleural Cancer Research Study Groups: Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
Pleural Cancer Clinical Trial 2023: Intensity-Modulated Pleural Radiation Therapy (IMPRINT) Highlights & Side Effects. Trial Name: NCT05354570 — Phase 2
Intensity-Modulated Pleural Radiation Therapy (IMPRINT) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05354570 — Phase 2
~11 spots leftby Apr 2026
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