Spots Global Cancer Trial Database for Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib
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Trial Identification
Brief Title: Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib
Official Title: The BAROCCO Study (Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib): an Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib With Continuous Schedule vs. Cediranib-Olaparib With Intermittent Schedule in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
Study ID: NCT03314740
Conditions
Study Description
Brief Summary: This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer. Patients will be randomised in a 1:1:1 ratio to three treatment arms: * Arm A: Paclitaxel 80 mg/mq every week * Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day * Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Spedali Civili di Brescia, Brescia, BS, Italy
Ospedale San Gerardo - ASST Monza, Monza, MB, Italy
Istituto Oncologico Veneto (IOV), Padova, PD, Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, RE, Italy
Policlinico Umberto I - Università La Sapienza, Rome, RM, Italy
Istituto Eurpeo di Oncologia (IEO), Milano, , Italy
Contact Details
Name: Roldano Fossati, MD
Affiliation: Mario Negri Institute for Pharmacological Research
Role: STUDY_DIRECTOR
Name: Nicoletta Colombo, MD
Affiliation: European Institute of Oncology
Role: PRINCIPAL_INVESTIGATOR
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