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

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ClinicalTrials.gov Identifier: NCT02273583
Recruitment Status : Unknown
Verified February 2016 by Antônio Sérgio Petrilli, Grupo de Apoio ao Adolescente e a Crianca com Cancer.
Recruitment status was:  Recruiting
First Posted : October 24, 2014
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Antônio Sérgio Petrilli, Grupo de Apoio ao Adolescente e a Crianca com Cancer

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.

Condition or disease Intervention/treatment Phase
High Grade Osteosarcoma Drug: continuous oral cyclophosphamide and methotrexate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 738 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2006
Actual Primary Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Maintenance therapy
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
No Intervention: Control
31 weeks of MAP.



Primary Outcome Measures :
  1. Event-Free Survival [ Time Frame: EFS AT 5 YEARS ]
    AT 5 YEARS


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: OS AT 5 YEARS ]
    AT 5 YEARS



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with high-grade malignancy osteosarcoma , biopsy-proven , newly diagnosed , previously untreated . Patients with osteosarcoma as a second malignancy should also be eligible .
  2. Patients with any primary site , with or without metastases at diagnosis , will be accepted and treated.
  3. Patients < 30 years.
  4. 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 .
  5. 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.
  6. Patients must have adequate cardiac function defined by a shortening fraction > 27 % by echocardiogram or ejection fraction > 47 % by radioisotopic angiogram .
  7. 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 .

  8. Whenever possible a central catheter should be placed against the intensity of chemotherapy and need for forced hydration .
  9. 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 .
  10. Time > than 4 weeks between biopsy and initiation of treatment - Restaging

Exclusion Criteria:

  1. 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 );
  2. Any properly documented clinical situation , which at the discretion of the attending physician , patient can not follow with chemotherapy , for safety reasons ;
  3. 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;
  4. The patient refusal to continue treatment ;
  5. Nephrotoxicity , neurotoxicity and ototoxicity grade 4 ;
  6. Delay greater than 40 days for the realization of the next treatment cycle , not related to toxicity;
  7. Refusal of surgery ; 8 . Variation above 20% of the recommended dose without justification.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273583


Contacts
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Contact: Sérgio Antônio Petrilli, MD 55-11-5080-8494 sergiopetrilli@graacc.org.br

Locations
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Brazil
GRAACC- Institute of Pediatric Oncology Recruiting
São Paulo, SP, Brazil, 04023-062
Contact: Antônio Sérgio Petrilli, MD    55-11-5080-8494    sergiopetrilli@graacc.org.br   
Principal Investigator: Antônio Sérgio Petrilli, MD         
Sponsors and Collaborators
Grupo de Apoio ao Adolescente e a Crianca com Cancer

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Responsible Party: Antônio Sérgio Petrilli, MD, PhD, Grupo de Apoio ao Adolescente e a Crianca com Cancer
ClinicalTrials.gov Identifier: NCT02273583     History of Changes
Other Study ID Numbers: GLATO 2006
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by Antônio Sérgio Petrilli, Grupo de Apoio ao Adolescente e a Crianca com Cancer:
of the extremity
Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Cyclophosphamide
Methotrexate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors