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出境医 / 临床实验 / Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation

Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation

Study Description
Brief 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. 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.


Condition or disease Intervention/treatment
Mediastinal Lymphoma Hodgkin Lymphoma Non Hodgkin Lymphoma Radiation: Standard treatment protocol with combined chemoradiation

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study With Longitudinal Cardiopulmonary Surveillance in Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : January 18, 2022
Estimated Study Completion Date : January 18, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
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.
Radiation: Standard treatment protocol with combined chemoradiation
As for consolidative RT used in patients with early-stage Hodgkin lymphoma, the RT field must essentially include the mediastinum.

Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in cardiac biomarkers. [ Time Frame: 1 year, 2 years, 3 years ]
    The outcome assessed by plasma concentrations of BNP and NT-proBNP

  2. Change in lung function. [ Time Frame: 1 year, 2 years, 3 years ]
    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".

  3. Change in cardiac systolic and diastolic functions including left ventricular global longitudinal strain. [ Time Frame: 1 year, 2 years, 3 years ]
    The outcomes assessed by echocardiography

  4. Significant toxicities. [ Time Frame: 1 year, 2 years, 3 years ]
    The outcome assessed by CTCAE v5.0

  5. Disease failure rate within radiation fields [ Time Frame: 3 years ]
  6. Event-free survival [ Time Frame: 3 years ]
  7. Overall survival [ Time Frame: 3 years ]
    Overall survival time, indicated by the time from the date of recruitment to the date of expiring

  8. Progression-Free Survival [ Time Frame: 3 years ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The lymphoma patients with mediastinal malignant lymphoma or patients whose radiation therapy field essentially encompasses anterior mediastinum.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Prior therapeutic radiation therapy delivered to breast, thoracic, or head & neck
  • Patients who have a serious medical illness
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Shinn-Yn Lin, M.D. +886-33281200 ext 7172 rt3126@gmail.com

Locations
Layout table for location information
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Shinn-Yn Lin, M.D.    +886-33281200 ext 7172    rt3126@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Tracking Information
First Submitted Date May 26, 2019
First Posted Date May 31, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date January 8, 2019
Estimated Primary Completion Date January 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 30, 2019)
  • Change in cardiac biomarkers. [ Time Frame: 1 year, 2 years, 3 years ]
    The outcome assessed by plasma concentrations of BNP and NT-proBNP
  • Change in lung function. [ Time Frame: 1 year, 2 years, 3 years ]
    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".
  • Change in cardiac systolic and diastolic functions including left ventricular global longitudinal strain. [ Time Frame: 1 year, 2 years, 3 years ]
    The outcomes assessed by echocardiography
  • Significant toxicities. [ Time Frame: 1 year, 2 years, 3 years ]
    The outcome assessed by CTCAE v5.0
  • Disease failure rate within radiation fields [ Time Frame: 3 years ]
  • Event-free survival [ Time Frame: 3 years ]
  • Overall survival [ Time Frame: 3 years ]
    Overall survival time, indicated by the time from the date of recruitment to the date of expiring
  • Progression-Free Survival [ Time Frame: 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation
Official Title A Prospective Observational Study With Longitudinal Cardiopulmonary Surveillance in Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation
Brief 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. 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The lymphoma patients with mediastinal malignant lymphoma or patients whose radiation therapy field essentially encompasses anterior mediastinum.
Condition
  • Mediastinal Lymphoma
  • Hodgkin Lymphoma
  • Non Hodgkin Lymphoma
Intervention Radiation: Standard treatment protocol with combined chemoradiation
As for consolidative RT used in patients with early-stage Hodgkin lymphoma, the RT field must essentially include the mediastinum.
Study Groups/Cohorts 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.
Intervention: Radiation: Standard treatment protocol with combined chemoradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 30, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 18, 2022
Estimated Primary Completion Date January 18, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Prior therapeutic radiation therapy delivered to breast, thoracic, or head & neck
  • Patients who have a serious medical illness
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shinn-Yn Lin, M.D. +886-33281200 ext 7172 rt3126@gmail.com
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03969693
Other Study ID Numbers 1810020038
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date January 2021

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