Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation
A legfontosabb adatok
- Ki végzi
- Chang Gung Memorial Hospital
- Hol
- Taoyuan (Tajvan)A helyszín megnézése
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 50 fő, tervezett
- Kezdés
- 2023. máj. 1.
- Várható befejezés
- 2028. dec. 31.
- A vizsgálat típusa
- Megfigyeléses
- A vizsgált kezelések
- Standard treatment protocol with combined chemoradiation
- A regiszteradat frissítve
- 2023. április 18.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan Hodgkin- vagy non-Hodgkin-limfómás embereket keres, akik kemoterápia után a mellkas középső részének (mediastinum) sugárkezelését kapják. A szívüket és a tüdejüket hosszabb időn át ellenőrzik.
- Életkor
- 15 és 80 év között
- Nem
- Minden nem részt vehet.
- A betegség stádiuma
- Szövettani vizsgálattal igazolt Hodgkin- vagy non-Hodgkin-limfóma. A sugárkezelési mezőnek érintenie kell a mediastinumot. Az eltávolított csecsemőmirigy-daganatú (timóma) beteg is részt vehet, ha műtét után sugárkezelésre küldik.
- Korábbi kezelés
- A limfóma típusához és stádiumához illő kemoterápiát be kell fejezni. A sugárkezelésnek a kemoterápia utáni kontrollvizsgálatok után egy hónapon belül el kell kezdődnie. Nem lehetett korábban sugárkezelése a mellen, a mellkason vagy a fej-nyak területén.
A részvétel fő kizáró okai
- Terhesség vagy szoptatás
- Korábbi sugárkezelés a mell, a mellkas vagy a fej-nyak területén
- Súlyos egyéb betegség
- Az ECOG 2-nél nem jobb általános állapot
- 12 hónapnál rövidebb várható élettartam
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Prior therapeutic radiation therapy delivered to breast, thoracic, or head \& neck
- Patients who have a serious medical illness
- Pregnant or breastfeeding
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 15 és 80 év között vagy?
Helyszínek itt: Tajvan
- Chang Gung Memorial HospitalTaoyuan, TajvanContact: Shinn-Yn Lin, M.D.No longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat csoportja
- 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.
Kezelés: Standard treatment protocol with combined chemoradiation
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Prospective Observational Study With Longitudinal Cardiopulmonary Surveillance in Lymphoma Patients Undergoing Mediastinal Radiotherapy in the Era of Modern Chemoradiation
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
- Illeszkedési kérdések
- Forrás: NCT03969693: ki vehet részt
- A regiszteradat frissítve
- 2023. április 18.