Mediastinal LymphomaNCT03969693
Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation
An observational study of Mediastinal Lymphoma and Hodgkin Lymphoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Malignant anterior mediastinal tumors essentially include lymphomas and thymomas. The location of mediastinum is anatomically close to several critical organs such as heart, lung, and breasts, which might be affected meaningfully when the mediastinal region is irradiated. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Mediastinal Lymphoma, Hodgkin Lymphoma, Non Hodgkin Lymphoma
- What is being tested?
- Standard treatment protocol with combined chemoradiation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The lymphoma patients with mediastinal malignant lymphoma or patients whose radiation therapy field essentially encompasses anterior mediastinum.
Who may be able to join
- Patients with an age of more than 15 years old when encountering local radiotherapy
- Histologically confirmed Hodgkin lymphoma or non-Hodgkin lymphoma
- A patient with resected thymoma referred for undergoing postoperative adjuvant radiotherapy is also acceptable and might be feasible
- The intended radiation field should involve the mediastinum region
- Malignant lymphoma patients who have undergone systemic chemotherapy with appropriate intensity and cycles tailored to the histologic subtype and oncological staging should start receiving RT within one month after restaging oncological surveys are performed before the course of mediastinal RT. Patient who must complete standard chemotherapy appropriate for the histologic subtype and staging of lymphoma and also be able to start radiation therapy within one month after restaging oncological surveys performed after completing chemotherapy
- Patients should have a fair to good performance status better than Eastern Cooperative Group (ECOG) of 2.
- Life expectancy of at least 12 months
Who cannot join
- Pregnant or breastfeeding
- Prior therapeutic radiation therapy delivered to breast, thoracic, or head \& neck
- Patients who have a serious medical illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chang Gung Memorial Hospital
Taoyuan, 333
Shinn-Yn Lin, M.D., +886-33281200 ext. 7172, rt3126@gmail.com
About this study
Official title: A Prospective Observational Study With Longitudinal Cardiopulmonary Surveillance in Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation
Malignant anterior mediastinal tumors essentially include lymphomas and thymomas. The location of mediastinum is anatomically close to several critical organs such as heart, lung, and breasts, which might be affected meaningfully when the mediastinal region is irradiated. There have been quite a few studies investigating long-term toxicities concerning the above critical organs and risks of secondary malignancies related to treatment regimens combining chemotherapy and mediastinal radiotherapy. With the advancement of modern radiotherapy, highly conformal and intensity modulated radiotherapy have become a radiotherapeutic standard in recent years. However, most previous studies analyzed patients treated in the era of 2D techniques rather than conformal 3D plans. Almost inevitably, a large volume of the heart and lung was irradiated via the 2D technique with which substantial dose levels might be given to these organs unavoidably. Certainly long-term radiotherapy related toxicities are significantly associated with the dose and volume irradiating the normal organs at risk. Relying on the techniques of modern conformal radiotherapy and the contemporary strategy of multimodality therapy, the dose and volume irradiating the heart and lung were considerably reduced. Therefore, objective tools including heart echocardiography and lung function test will be utilized in this prospective study to evaluate and monitor mainly the patients diagnosed as malignant lymphoma who are recommended to receive mediastinal radiotherapy in the era of modern treatment strategy and techniques.
The participants potentially included in the current study are mainly lymphoma patients with mediastinal malignant lymphoma or patients whose radiation therapy field essentially encompasses anterior mediastinum. Patients are prospectively enrolled in this study after physicians' clinical judgement. After signing the consent form, the recruited patient will receive comprehensive pre-radiotherapy evaluations, including cardiac echocardiography, laboratory tests (BNP, and NT-pro BNP), and lung function tests. Participants who are particularly female patients under the age of 45 will receive pre-radiotherapy breast echocardiography. Radiotherapy treatment planning of both photon and proton respectively will be simulated on Eclipse® treatment planning system. Subsequently participants will receive mediastinal RT within one month after being enrolled in the study. Eligible patients should receive standard multidisciplinary treatment as the tumor board at our institute has suggested. Modern radiotherapy techniques comprise all available modalities in our hospital, including photon or proton beams, intensity-modulated radiotherapy, volumetric modulated arc therapy, image-guidance, and breathing control system. The prescription of treatment field designing and dose scheme will comply with our institutional protocols and updated cancer treatment guidelines. Participants will receive longitudinal follow-up examinations at 3, 6, 9, 12, 18, 24, 36 months after the start of RT course. Standardized examinations include the above mentioned cardiac echocardiography and relevant tests.
Read more
It is anticipated that long-term mediastinal RT-related late effects are prospectively and longitudinally surveyed through consistent heart examinations and lung function tests. Long-term effects are expected to be lower with using maturely and widely adopted modern RT techniques. Therapeutic and survival outcomes are expected to be satisfactory, achieving the international level in this prospective observational study focusing on mainly lymphoma patients with mediastinal involvement who are suggested and scheduled to receive mediastinal RT as part of the combined modality treatment.
This study aims to standardize the application of clinical examinations including cardiac echocardiography, lung function tests, and relevant laboratory tests as part of objective tools for monitoring patients' cardiac and pulmonary functions after receiving mediastinal RT. Therefore, it is expected that the risk factors of predisposing patients to develop cardiac toxicities after chemoradiation particularly including mediastinal RT will be explored and identified. In addition objectivity of BNP (or NT-pro BNP) will also be verified in combination with the objective measurement and findings obtained from cardiac echocardiography. It is anticipated that our study would be an important and leading one that integrates radiation oncology, hematology, cardiology, and pulmonology into prospective and longitudinal cardiopulmonary surveillance carried out for mainly malignant lymphoma patients undergoing mediastinal RT in this era of modern chemoradiation.
- Conditions
- Mediastinal Lymphoma, Hodgkin Lymphoma, Non Hodgkin Lymphoma
- Being tested
- Standard treatment protocol with combined chemoradiation
- Keywords
- Lymphoma, Radiotherapy, Mediastinum, Adverse effects, Longitudinal, Cardiac toxicities, Lung, Breast
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment protocol with combined chemoradiationRadiation
As for consolidative RT used in patients with early-stage Hodgkin lymphoma, the RT field must essentially include the mediastinum.
| Study group | Role | What they receive |
|---|---|---|
| The patients with mediastinal malignant lymphoma | Patients whose radiation therapy field essentially encompasses anterior mediastinum; namely, the majority of malignant lymphoma patients with mediastinal involvement. Receives: Radiation: Standard treatment protocol with combined chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart function.
The outcome assessed by cardiac echocardiography. Our study use the standard imaging modality -cardiac echocardiography
Measured: 12 month, and 24 month.
Secondary outcomes (8)
Change in cardiac biomarkers.
The outcome assessed by plasma concentrations of BNP and NT-proBNP
Measured: 1 year, 2 years, 3 years
Change in lung function.
The outcome assessed by lung function test. The lung function tests contain following four tests: "Determination of F. R. C" \& "Diffusion capacity rate" \& "Screening sporometry before \& after B. D." and "Simple bronchodilator test".
Measured: 1 year, 2 years, 3 years
Change in cardiac systolic and diastolic functions including left ventricular global longitudinal strain.
The outcomes assessed by echocardiography
Measured: 1 year, 2 years, 3 years
Significant toxicities.
The outcome assessed by CTCAE v5.0
Measured: 1 year, 2 years, 3 years
Disease failure rate within radiation fields
Measured: 3 years
Event-free survival
Measured: 3 years
Overall survival
Overall survival time, indicated by the time from the date of recruitment to the date of expiring
Measured: 3 years
Progression-Free Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal LymphomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969693
- Sponsor's protocol ID
- 1810020038
- Status last verified
- Apr 2023
- First submitted
- 26 May 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study With Longitudinal Cardiopulmonary Surveillance in Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation
- ClinicalTrials.gov ID
- NCT03969693
- Acronym / sponsor ID
- 1810020038
- Conditions
- Mediastinal Lymphoma, Hodgkin Lymphoma, Non Hodgkin Lymphoma
- Keywords
- Lymphoma, Radiotherapy, Mediastinum, Adverse effects, Longitudinal, Cardiac toxicities, Lung, Breast
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malignant anterior mediastinal tumors essentially include lymphomas and thymomas. The location of mediastinum is anatomically close to several critical organs such as heart, lung, and breasts, which might be affected meaningfully when the mediastinal region is irradiated. There have been quite a few studies investigating long-term toxicities concerning the above critical organs and risks of secondary malignancies related to treatment regimens combining chemotherapy and mediastinal radiotherapy. With the advancement of modern radiotherapy, highly conformal and intensity modulated radiotherapy have become a radiotherapeutic standard in recent years. However, most previous studies analyzed patients treated in the era of 2D techniques rather than conformal 3D plans. Almost inevitably, a large volume of the heart and lung was irradiated via the 2D technique with which substantial dose levels might be given to these organs unavoidably. Certainly long-term radiotherapy related toxicities are significantly associated with the dose and volume irradiating the normal organs at risk. Relying on the techniques of modern conformal radiotherapy and the contemporary strategy of multimodality therapy, the dose and volume irradiating the heart and lung were considerably reduced. Therefore, objective tools including heart echocardiography and lung function test will be utilized in this prospective study to evaluate and monitor mainly the patients diagnosed as malignant lymphoma who are recommended to receive mediastinal radiotherapy in the era of modern treatment strategy and techniques.
The participants potentially included in the current study are mainly lymphoma patients with mediastinal malignant lymphoma or patients whose radiation therapy field essentially encompasses anterior mediastinum. Patients are prospectively enrolled in this study after physicians' clinical judgement. After signing the consent form, the recruited patient will receive comprehensive pre-radiotherapy evaluations, including cardiac echocardiography, laboratory tests (BNP, and NT-pro BNP), and lung function tests. Participants who are particularly female patients under the age of 45 will receive pre-radiotherapy breast echocardiography. Radiotherapy treatment planning of both photon and proton respectively will be simulated on Eclipse® treatment planning system. Subsequently participants will receive mediastinal RT within one month after being enrolled in the study. Eligible patients should receive standard multidisciplinary treatment as the tumor board at our institute has suggested. Modern radiotherapy techniques comprise all available modalities in our hospital, including photon or proton beams, intensity-modulated radiotherapy, volumetric modulated arc therapy, image-guidance, and breathing control system. The prescription of treatment field designing and dose scheme will comply with our institutional protocols and updated cancer treatment guidelines. Participants will receive longitudinal follow-up examinations at 3, 6, 9, 12, 18, 24, 36 months after the start of RT course. Standardized examinations include the above mentioned cardiac echocardiography and relevant tests.
It is anticipated that long-term mediastinal RT-related late effects are prospectively and longitudinally surveyed through consistent heart examinations and lung function tests. Long-term effects are expected to be lower with using maturely and widely adopted modern RT techniques. Therapeutic and survival outcomes are expected to be satisfactory, achieving the international level in this prospective observational study focusing on mainly lymphoma patients with mediastinal involvement who are suggested and scheduled to receive mediastinal RT as part of the combined modality treatment.
This study aims to standardize the application of clinical examinations including cardiac echocardiography, lung function tests, and relevant laboratory tests as part of objective tools for monitoring patients' cardiac and pulmonary functions after receiving mediastinal RT. Therefore, it is expected that the risk factors of predisposing patients to develop cardiac toxicities after chemoradiation particularly including mediastinal RT will be explored and identified. In addition objectivity of BNP (or NT-pro BNP) will also be verified in combination with the objective measurement and findings obtained from cardiac echocardiography. It is anticipated that our study would be an important and leading one that integrates radiation oncology, hematology, cardiology, and pulmonology into prospective and longitudinal cardiopulmonary surveillance carried out for mainly malignant lymphoma patients undergoing mediastinal RT in this era of modern chemoradiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The patients with mediastinal malignant lymphoma | – | Radiation: Standard treatment protocol with combined chemoradiationPatients whose radiation therapy field essentially encompasses anterior mediastinum; namely, the majority of malignant lymphoma patients with mediastinal involvement. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The lymphoma patients with mediastinal malignant lymphoma or patients whose radiation therapy field essentially encompasses anterior mediastinum.
Key inclusion criteria (7 listed)
- Patients with an age of more than 15 years old when encountering local radiotherapy
- Histologically confirmed Hodgkin lymphoma or non-Hodgkin lymphoma
- A patient with resected thymoma referred for undergoing postoperative adjuvant radiotherapy is also acceptable and might be feasible
- The intended radiation field should involve the mediastinum region
- Malignant lymphoma patients who have undergone systemic chemotherapy with appropriate intensity and cycles tailored to the histologic subtype and oncological staging should start receiving RT within one month after restaging oncological surveys are performed before the course of mediastinal RT. Patient who must complete standard chemotherapy appropriate for the histologic subtype and staging of lymphoma and also be able to start radiation therapy within one month after restaging oncological surveys performed after completing chemotherapy
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding
- Prior therapeutic radiation therapy delivered to breast, thoracic, or head \& neck
- Patients who have a serious medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatment protocol with combined chemoradiationAs for consolidative RT used in patients with early-stage Hodgkin lymphoma, the RT field must essentially include the mediastinum. | Radiation | The patients with mediastinal malignant lymphoma |
Primary outcome
Change in heart function.
Time frame: 12 month, and 24 month.
The outcome assessed by cardiac echocardiography. Our study use the standard imaging modality -cardiac echocardiography
8 secondary outcomes
Change in cardiac biomarkers.
Time frame: 1 year, 2 years, 3 years
Change in lung function.
Time frame: 1 year, 2 years, 3 years
Change in cardiac systolic and diastolic functions including left ventricular global longitudinal strain.
Time frame: 1 year, 2 years, 3 years
Significant toxicities.
Time frame: 1 year, 2 years, 3 years
Disease failure rate within radiation fields
Time frame: 3 years
Event-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Progression-Free Survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediastinal Lymphoma and Hodgkin Lymphoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shinn-Yn Lin, M.D. (+886-33281200 ext. 7172, rt3126@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart function. (time frame: 12 month, and 24 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.