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

NCT02273583 | Unknown Phase 2 DMC

• 1 other identifier: GLATO 2006
• Study Type: interventional
• Target: 738
• Locations: 1 country
• Sites: 1

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.

Conditions

High Grade Osteosarcoma

Keywords

of the extremity

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival

  AT 5 YEARS

  EFS AT 5 YEARS

Secondary Outcomes (1)

• Overall survival

  OS AT 5 YEARS

Study Arms (2)

Maintenance therapy

EXPERIMENTAL

73 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP.

Drug: continuous oral cyclophosphamide and methotrexate

Control

NO INTERVENTION

31 weeks of MAP.

Interventions

continuous oral cyclophosphamide and methotrexate DRUG

Maintenance therapy

Eligibility Criteria

• Age: 1 Day - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with high-grade malignancy osteosarcoma , biopsy-proven , newly diagnosed , previously untreated . Patients with osteosarcoma as a second malignancy should also be eligible .
• Patients with any primary site , with or without metastases at diagnosis , will be accepted and treated.
• Patients \< 30 years.
• Patients must have normal body function and adequate renal function defined as serum creatinine \< 1.5 x the normal value or creatinine clearance \> 60ml/min/1 ,73m2 .
• Patients must have adequate hepatic function, defined as total bilirubin \< 1.5 x normal, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \< 2.5 x normal.
• Patients must have adequate cardiac function defined by a shortening fraction \> 27 % by echocardiogram or ejection fraction \> 47 % by radioisotopic angiogram .
• If pre- chemotherapy amputation is necessary, the patient is included in the study and eligible to survival analyzes, however the pathological analyze response will be not performed.
• Obtain material for pathological and molecular study is recommended .
• Whenever possible a central catheter should be placed against the intensity of chemotherapy and need for forced hydration .
• Patient or legal guardian must sign a consent form which will be explain the type of treatment and procedures that the patient will be submitted .
• Time \> than 4 weeks between biopsy and initiation of treatment - Restaging

You may not qualify if:

• Disease progression ( increase of at least 20% of the extent of the lesion, taking as reference the smallest measurement recorded from the start of treatment, or the appearance of one or more lesions );
• Any properly documented clinical situation , which at the discretion of the attending physician , patient can not follow with chemotherapy , for safety reasons ;
• The evaluation of cardiac aspects will be done carefully , so will exclude patients with 20% reduction in the ejection fraction of the left ventricle compared to baseline or with a ventricular ejection fraction \< 45 % regardless of baseline;
• The patient refusal to continue treatment ;
• Nephrotoxicity , neurotoxicity and ototoxicity grade 4 ;
• Delay greater than 40 days for the realization of the next treatment cycle , not related to toxicity;
• Refusal of surgery ; 8 . Variation above 20% of the recommended dose without justification.

Sponsors & Collaborators

• Grupo de Apoio ao Adolescente e a Crianca com Cancer: lead

Study Sites (1)

GRAACC- Institute of Pediatric Oncology

São Paulo, São Paulo, 04023-062, Brazil

RECRUITING

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Sérgio Antônio Petrilli, MD

CONTACT

55-11-5080-8494; sergiopetrilli@graacc.org.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: October 24, 2014
• Study Start: May 1, 2006
• Primary Completion: June 1, 2013
• Last Updated: February 11, 2016

Record last verified: 2016-02

Locations

BR (1)