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Radiation
IMPRINT Radiation Therapy for Thymic Cancer
Phase 2
Recruiting
Led By Annemarie Shepherd, 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
assess the rate of radiation pneumonitis
Secondary outcome measures
progression-free survival (PFS)
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
1,936 Previous Clinical Trials
588,862 Total Patients Enrolled
Annemarie Shepherd, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not using any form of birth control.I was hospitalized for heart failure in the last 30 days.My cancer is confirmed to be thymic malignancy or thymic carcinoma.I had a kidney removed on the opposite side of my chest cancer spread.My kidney function is good enough for the treatment.I am having or have had surgery to remove lung or pleural nodules.I haven't had a severe heart attack or unstable angina in the last 3 months.I have a history of lung scarring or fibrosis.My cancer has spread to the lining of my lungs.I am between 18 and 80 years old.My cancer has not spread outside my chest or to the opposite side of my chest.I use oxygen all the time.My cancer has spread to the lining of my lungs.My lung function tests show I have more than 40% of the expected capacity.I've had chest radiation that now prevents certain lung treatments, but I may have had thymus or specific pleural radiation.My cancer has not spread outside my chest or to the opposite side of my chest.I have a history of myasthenia gravis.My cancer is confirmed to be thymic malignancy or thymic carcinoma.I can carry out normal activities with minimal symptoms.I take more than 10 mg of prednisone daily for my COPD.
Research Study Groups:
This trial has the following groups:- Group 1: Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial available to individuals aged 85 and over?
"This medical trial seeks to include participants that are between 18 years of age and 79 years old."
Answered by AI
Are there any vacancies available to join this investigation?
"Correct. Clinicaltrials.gov reports that, after being posted on April 26th 2022 and last edited on May 2nd 2022, this medical study is actively recruiting patients."
Answered by AI
To what extent does IMPRINT pose a risk to those undergoing treatment?
"Our team's assessment of the safety profile of Intensity-Modulated Pleural Radiation Therapy (IMPRINT) is a 2 due to this being a Phase 2 trial. While there has been data collected regarding its safety, no efficacy results have yet been reported."
Answered by AI
Is there an opportunity for me to participate in this research endeavor?
"To be accepted into this medical trial, prospective patients must have active metastasis and between 18 to 79 years of age. The total number of participants needed is 36 individuals."
Answered by AI
In what geographical regions can this clinical trial be accessed?
"Presently, 8 different sites are executing this investigation. These centres can be found in Basking Ridge, Harrison and Rockville Centre as well as 5 other areas. To minimize the need for travel during your enrollment process, it is advantageous to pick a clinic that is closest to you."
Answered by AI
What is the limit of participants taking part in this research endeavor?
"Affirmative. The information on clinicaltrials.gov confirms that this medical study, which was initially posted 4/26/2022, is actively recruiting participants. A total of 36 individuals must be sourced from 8 different sites in order to meet the trial's requirements."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Memoral Sloan Kettering Basking Ridge (Limited protocol activities)
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
What portion of applicants met pre-screening criteria?
Met criteria
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