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Spots Global Cancer Trial Database for Prospective Clinical Trial Evaluating Metronomic Chemotherapy in Patients With High-grade, Operable, Non-metastatic Osteosarcoma of the Extremity

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Trial Identification

Brief Title: Prospective Clinical Trial Evaluating Metronomic Chemotherapy in Patients With High-grade, Operable, Non-metastatic Osteosarcoma of the Extremity

Official Title:

Study ID: NCT02273583

Study Description

Brief Summary: Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with high grade, operable, non-metastatic osteosarcoma (OST) of the extremities. The primary end point is event-free survival (EFS) from randomization.

Detailed Description: The study design includes a backbone of 10 weeks of preoperative therapy using MAP (High-dose methotrexate, cisplatin, and doxorubicin). Following surgery, non-metastatic patients were randomized by blocks to complete 31 weeks of MAP or to receive 73 weeks of maintenance therapy following MAP; while metastatic patients received maintenance therapy in combination with MAP since the beginning of treatment.

Eligibility

Minimum Age: 1 Day

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

GRAACC- Institute of Pediatric Oncology, São Paulo, SP, Brazil

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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