Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ewing Sarcoma
- Osteosarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Group 1 Localized osteosarcoma that have presented a response ? 60% to the pre-operatory chemotherapy. Is expected the enrolment of 37 patients as total population, in 44 months. The patients will be followed for 3 years, started from the date of enrolment. Metformin will be administrated for 3 years maximum, unless there is a progression disease or if toxicity is verified. Group 2 Osteosarcoma and Ewing sarcoma patients with complete remission after the first relapse. Is expected the enrolment of 30 patients as total population, in 24 months. Metformin will be administrated at the Group 2 for 1 year. If there is no toxicity verified or relapse, the patient should continue the treatment for other 2 year (in a total 3 years as maximum).Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 14 years and 125 years
- Gender
- Both males and females
Description
MATERIALS & METHODS The study is divided in two groups 1. Group 1-Localized osteosarcoma that have reported a post neoadjuvant chemotherapy primary tumor necrosis ? 60% Metformin will be administrated for 3 years maximum or until progression disease or if G3 or G4 toxicity is verified. 37 patients a...
MATERIALS & METHODS The study is divided in two groups 1. Group 1-Localized osteosarcoma that have reported a post neoadjuvant chemotherapy primary tumor necrosis ? 60% Metformin will be administrated for 3 years maximum or until progression disease or if G3 or G4 toxicity is verified. 37 patients as total population are necessary to evaluate a 3 yrs increase of EFS from 35% ( historical data Tsuda Y ) to 60%, 2. Group 2 Osteosarcoma and Ewing sarcoma patients in Complete Remission after the first relapse.Metformin will be administrated for 3 years or until progression . The Event Free Survival of this second group will be calculated at 1 yr with the aim of an increase of EFS from 20%(historical data) to 45% STATISTICAL ANALYSIS AND SAMPLE SIZE Sample size was calculated by the Expected Total Study Length minimization criteria to ensure a potency parameter of 80 % and point if there is a benefit in use Metformin compared to the historical control. EFS will be estimated by Kaplan-Meier and the standard error will be used to calculate the interim analysis Z-factor as well as the final statistical analysis. The final statistical analysis will be performed Group 1 after 3 years after last patient enrollment Group 2 at 1 year from the last patient enrollment : EFS at 1 year OBJECTIVE Evaluate the event free survival (EFS) in osteosarcoma and Ewing sarcoma patients with high risk of relapse compared to the historical control. Evaluate Metformin's toxicity as maintenance therapy.
Tracking Information
- NCT #
- NCT04758000
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alessandra Longhi, MD Istituto Ortopedico Rizzoli IRCSS, Bologna, Italy
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