IMPRINT Radiation Therapy for Thymic Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Must not be taking: Chronic oral steroids
Disqualifiers: Continuous oxygen, Myasthenia gravis, Nephrectomy, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic oral steroid therapy for COPD, you may not be eligible to participate.
What data supports the effectiveness of the treatment Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for thymic cancer?
Research shows that intensity-modulated pleural radiation therapy (IMPRINT) has been effective in treating malignant pleural mesothelioma, a type of cancer affecting the lining of the lungs, by improving tumor control and reducing side effects compared to older methods. This suggests that IMPRINT could potentially be effective for thymic cancer as well, given its success in similar conditions.
12345Is IMPRINT radiation therapy generally safe for humans?
IMPRINT radiation therapy has been studied for safety in conditions like malignant pleural mesothelioma and thymoma. The studies show that it meets safety standards for organs like the lungs, heart, and esophagus, with low complication probabilities, indicating it is generally safe for humans.
12567How is IMPRINT treatment different from other treatments for thymic cancer?
IMPRINT treatment is unique because it uses advanced radiation techniques to target the pleura (the lining of the lungs) while sparing the lung itself, which may reduce damage to nearby organs like the heart and esophagus compared to conventional radiation therapies.
23789Eligibility Criteria
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.Inclusion Criteria
My cancer is confirmed to be thymic malignancy or thymic carcinoma.
My kidney function is good enough for the treatment.
My cancer has spread to the lining of my lungs.
+8 more
Exclusion Criteria
I am not using any form of birth control.
I was hospitalized for heart failure in the last 30 days.
Pregnant or lactating women
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) over approximately 6 weeks
6 weeks
28 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including progression-free survival and radiation pneumonitis
12 months
Participant Groups
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.
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.
Intensity-Modulated Pleural Radiation Therapy (IMPRINT) is already approved in United States, European Union, Japan for the following indications:
🇺🇸 Approved in United States as IMPRINT for:
- Thymic cancer with pleural metastases
🇪🇺 Approved in European Union as IMPRINT for:
- Thymic malignancies with pleural dissemination
🇯🇵 Approved in Japan as IMPRINT for:
- Thymic carcinoma with pleural metastases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memoral Sloan Kettering Basking Ridge (Limited protocol activities)Basking Ridge, NJ
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)Basking Ridge, NJ
Memorial Sloan Kettering Monmouth (Limited protocol activities)Middletown, NJ
Memorial Sloan Kettering Bergen (Limited protocol activities)Montvale, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Intensity Modulated Radiation Therapy for Pleural Recurrence of Thymoma: A Prospective Phase 2 Study. [2021]This study aimed to evaluate the efficacy and safety of intensity modulated radiation therapy (IMRT) for pleural recurrence of thymoma that was not suitable for surgery and had progressed after chemotherapy.
Phase II Study of Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) As Part of Lung-Sparing Multimodality Therapy in Patients With Malignant Pleural Mesothelioma. [2022]We conducted a two-center phase II study to determine the safety of hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) after chemotherapy and pleurectomy-decortication (P/D) as part of a multimodality lung-sparing treatment.
Improved Outcomes with Modern Lung-Sparing Trimodality Therapy in Patients with Malignant Pleural Mesothelioma. [2021]Higher target conformity and better sparing of organs at risk with modern radiotherapy (RT) may result in higher tumor control and less toxicity. In this study, we compare our institutional multimodality therapy experience of adjuvant chemotherapy and hemithoracic intensity-modulated pleural RT (IMPRINT) with previously used adjuvant conventional RT (CONV) in patients with malignant pleural mesothelioma (MPM) treated with lung-sparing pleurectomy/decortication (P/D).
Computed tomography features of local pleural recurrence in patients with malignant pleural mesothelioma treated with intensity-modulated pleural radiation therapy. [2021]This study was conducted in order to describe the computed tomography (CT) features of local pleural recurrence in patients with malignant pleural mesothelioma undergoing intensity-modulated pleural radiation therapy (IMPRINT) as part of multimodality treatment.
Even low doses of radiation lead to DNA damage accumulation in lung tissue according to the genetically-defined DNA repair capacity. [2018]Intensity-modulated radiation therapy for thoracic malignancies increases the exposure of healthy lung tissue to low-dose radiation. The biological impact of repetitive low-dose radiation on the radiosensitive lung is unclear.
NTCP Calculations of Five Different Irradiation Techniques for the Treatment of Thymoma. [2023]This study provided normal tissue complication probability (NTCP) calculations from photon radiotherapy techniques in eleven patients with thymoma. Five plans were created for each participant using three-dimensional conformal radiotherapy (3D-CRT), five-field intensity modulated radiotherapy (5F-IMRT), seven-field IMRT (7F-IMRT), and volumetric modulated arc therapy with full arcs (FA-VMAT) and partial arcs (PA-VMAT). The target coverage, homogeneity index and conformation number for the planning target volume (PTV) and dosimetric parameters for the organs-at-risk (OARs) were taken from the fifty-five generated plans. The patient-specific NTCP of the lungs, heart and esophagus was calculated with an in-house software tool using differential dose-volume histograms and the equivalent uniform dose model. The PTV dose metrics from 3D-CRT were inferior to those from IMRT and VMAT plans. The dose constraints for the OARs were met in all treatment plans. The NTCP range of the lungs, heart and esophagus was 0.34-0.49%, 0.03-0.06% and 0.08-0.10%, respectively. The NTCPs of the heart for the incidence of peridarditis from IMRT and VMAT were significantly smaller than those from conformal treatment (p < 0.05). The 7F-IMRT was significantly superior to FA-VMAT in reducing the NTCP of the lungs and the risk of pneumonitis (p = 0.001). Similar superiority of 5F-IMRT over PA-VMAT for lung protection was found (p = 0.009). The presented results may be employed in the selection of the appropriate irradiation technique for restricting the complications in the adjacent OARs.
Invasive thymoma: postoperative mediastinal irradiation, and low-dose entire hemithorax irradiation in patients with pleural dissemination. [2016]We evaluated the results of postoperative mediastinal radiotherapy (MRT) for invasive thymoma and low-dose entire hemithorax radiotherapy (EHRT) for pleural dissemination.
Rationale and early outcomes for the management of thymoma with proton therapy. [2022]Radiotherapy for thymic malignancies is technically challenging due to their close proximity to the heart, lungs, esophagus, and breasts, raising concerns about significant acute and late toxicities from conventional photon radiotherapy. Proton therapy (PT) may reduce the radiation dose to these vital organs, leading to less toxicity. We reviewed the dosimetry and outcomes among patients treated with PT for thymic malignancies at our institution.
High-dose hemithorax irradiation in a patient with recurrent thymoma: a study of pulmonary and cardiac radiation tolerance. [2019]Malignancy spread throughout a hemithorax without distant metastasis poses a difficult therapeutic challenge. Irradiation is often not considered because of the risk of pulmonary and cardiac toxicity. We report on a patient with thymoma recurrent throughout the left pleural cavity. Disease progressed despite chemotherapy, and subsequently a radical course of radiotherapy (6,600 cGy) was delivered to the entire hemithorax. Tumor regressed markedly by the completion of radiotherapy. Although tumor regrowth was noted 1 year after radiotherapy, the patient remained markedly improved symptomatically until shortly before her death 2 years after radiotherapy. Pulmonary function tests at 1 year (forced expiratory volume of the first second and forced vital capacity) were similar to pretreatment values, and cardiac function at 2 years remained essentially normal. High-dose hemithorax irradiation may be a consideration in select cases.