The CARTIER study is a randomized, multicenter, open-label clinical trial comparing, in elderly patients with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies: primary (intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care) vs. secondary (current clinical practice where intensive cardiovascular monitoring is not routinely performed and cardiotoxicity patient care is based on the onco-hematologist criteria). The primary endpoint is to determine whether this primary prevention englobing cardiovascular monitoring plus intensive multidisciplinary management is superior to the current clinical practice in reducing all cause mortality. Other secondary objectives of the study are to analyze the impact of this intensive cardiovascular monitoring strategy on the incidence of cardiovascular mortality, oncological mortality, hospitalization and/or urgent care due to cardiovascular complications, hospitalization and/or urgent oncological care due to cancer complications, tumor progression and cost-effectiveness analysis. A total of 514 patients ≥ 65 years old diagnosed with any of the following onco-hematological cancers, colon, breast, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia or myeloma, undergoing standardized anti-tumoral treatment, will be recruited. The incidence of primary and secondary outcomes will be measured at 2 and 5 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
514
Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; EKG; Echocardiogram; Biomarkers (troponin and natriuretic peptide); Structured counselling on healthy cardiac practices; Treatment optimization of cardiovascular risk factors and heart diseases; Quality of life (ECOG Performance status and Minnesota questionnaires); Interaction and management of patient care by the cardio-onco-hematology team. Moreover, cardiac MRI in centers participating in the CARTIER-MR sub-study.
Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; ECOG Performance status; cardiac patient care based on the onco-hematologist criteria
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
NOT_YET_RECRUITINGHospital de Galdakao-Usansolo
Galdakao, Vizcaya, Spain
NOT_YET_RECRUITINGHospital Universitario Vall d´Hebron
Barcelona, Spain
NOT_YET_RECRUITINGHospital Universitario Reina Sofía
Córdoba, Spain
NOT_YET_RECRUITINGHospital Universitario de La Princesa
Madrid, Spain
NOT_YET_RECRUITINGHospital G. Universitario Gregorio Marañón
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario Ramón y Cajal
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario Fundación Jiménez Díaz
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario 12 de Octubre
Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario Puerta de Hierro
Madrid, Spain
NOT_YET_RECRUITING...and 4 more locations
All-cause mortality
Cumulative incidence of all-cause mortality
Time frame: Two (mid-term analysis) and five years of follow-up
Oncological mortality
Cumulative incidence of oncological mortality
Time frame: Two and five years of follow-up
Cardiovascular mortality
Cumulative incidence of cardiovascular mortality
Time frame: Two and five years of follow-up
Hospitalization
Cumulative incidence of hospitalization
Time frame: Two and five years of follow-up
Hospitalization/emergency cardiovascular cause
Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause
Time frame: Two and five years of follow-up
Hospitalization/emergency cancer cause
Cumulative incidence of hospitalization and/or emergency care for cancer cause
Time frame: Two and five years of follow-up
Tumor recurrence or progression
Incidence of tumoral recurrence or progression
Time frame: Two and five years of follow-up
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