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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Shinn-Yn Lin, M.D. contact

+886-33281200 ext. 7172

rt3126@gmail.com

Taiwan1 site
  • Chang Gung Memorial Hospital

    Taoyuan, 333

    Shinn-Yn Lin, M.D., +886-33281200 ext. 7172, rt3126@gmail.com

Other trials in Taiwan

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.

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 groups in NCT03969693
Study groupRoleWhat they receive
The patients with mediastinal malignant lymphomaPatients 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.

  1. 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)
  1. Change in cardiac biomarkers.

    The outcome assessed by plasma concentrations of BNP and NT-proBNP

    Measured: 1 year, 2 years, 3 years

  2. 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

  3. 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

  4. Significant toxicities.

    The outcome assessed by CTCAE v5.0

    Measured: 1 year, 2 years, 3 years

  5. Disease failure rate within radiation fields

    Measured: 3 years

  6. Event-free survival

    Measured: 3 years

  7. Overall survival

    Overall survival time, indicated by the time from the date of recruitment to the date of expiring

    Measured: 3 years

  8. 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.

  1. First posted31 May 2019
  2. Study start1 May 2023 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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)
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

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.

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