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Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma

NCT03063983 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2017-03-13

No results posted yet for this study

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, metastatic osteosarcoma (OST) of the extremities. The primary end point is event-free survival (EFS) from randomization

Conditions

Interventions

DRUG

Cyclophosphamide

Continuous oral cyclophosphamide

DRUG

Methotrexate

Continuous oral methotrexate

Sponsors & Collaborators

  • Grupo de Apoio ao Adolescente e a Crianca com Cancer

    lead OTHER

Principal Investigators

  • Cláudia F Fontes · Grupo de Apoio ao Adolescente e a Crianca com Cancer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-02
Primary Completion
2019-01-02
Completion
2022-01-31
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063983 on ClinicalTrials.gov