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Brief Title: Low Dose Continuous Cyclophosphamide vs Standard Doxorubicin in Advanced Sarcoma Elderly Patients
Official Title: The METROPHOLYS Study Metronomic Cyclophosphamide vs Doxorubicin in Elderly Patients With Advanced Soft Tissue Sarcomas Randomized, Controlled Open Label Clinical Trial
Study ID: NCT04656262
Brief Summary: To compare the efficacy, as measured by time to treatment failure, of metronomic cyclophosphamide with respect to doxorubicin in elderly patients affected by mSTS.
Detailed Description: This phase III randomized clinical trial was designed to compare metronomic Cyclophosphamide with standard Doxorubicin for the first-line treatment of elderly cancer patients with advanced inoperable or metastatic STS: i) ARM A (experimental): Metronomic Cyclophosphamide ii) ARM B (control): Doxorubicin up to six cycles
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Policlinico Sant'Orsola Malpighi, Bologna, BO, Italy
Istituto Clinico Humanitas, Rozzano, MI, Italy
Istituto Ortopedico Rizzoli IRCCS, Bologna, , Italy
Fondazione del Piemonte per l'Oncologia IRCCS, Candiolo, , Italy
IRST Romagnolo IRCCS, Meldola, , Italy
Istituto Nazionale Tumori IRCCS, Milano, , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
AOU Policlinico Giaccone Palermo, Palermo, , Italy
Ospedale Misericordia e Dolce, Prato, , Italy
Policlinico Universitario Campus Biomedico, Roma, , Italy
IFO - Istituto Regina Elena, Roma, , Italy
Presidio Sanitario Humanitas - Gradenico, Torino, , Italy
AOUI Policlinico Borgo Roma, Verona, , Italy
Name: Antonella Brunello
Affiliation: Istituto Oncologico Veneto
Role: PRINCIPAL_INVESTIGATOR