Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma

  • STATUS
    Recruiting
  • days left to enroll
    12
  • participants needed
    158
  • sponsor
    Grupo de Apoio ao Adolescente e a Crianca com Cancer
Updated on 21 January 2021
cancer
methotrexate
cancer chemotherapy
metastatic osteosarcoma

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

Description

The study design includes backbone of 10 weeks of preoperative therapy using MAP (high-dose methotrexate, cisplatin, doxorubicin and dexrazoxane). Metastatic patients were randomized to high-dose chemotherapy for 31 weeks (arm 1) or concomitant metronomic therapy (MTX plus cyclophosphamide) such as 31 weeks of high-dose chemotherapy, followed by 73 weeks of metronomic therapy after completion of high-dose chemotherapy, totaling 104 weeks of metronomic therapy (arm 2).

Details
Condition Osteosarcoma, Osteosarcoma, Sarcoma, Sarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma, bone sarcoma
Treatment cyclophosphamide, methotrexate
Clinical Study IdentifierNCT03063983
SponsorGrupo de Apoio ao Adolescente e a Crianca com Cancer
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

A newly diagnosed patient, previously untreated, with a high degree of malignancy, confirmed by biopsy. Participant with OST as a neoplasm are also eligible
Participant with staging imaging studies performed less than four weeks. Otherwise, it should be re-staged
If pre-chemotherapy amputation is necessary, the participant will enter the study being excluded from the evaluation of tumor necrosis grade according to Huvos, but eligible for survival analysis
Participant aged 16 years should have a Karnofsky performance score> 50 or WHO / ECOG 2 and patients <16 years should have a Lansky performance score> 50\. Participant with a performance score impaired by the presence of a pathological fracture are eligible
Patients with normal organic function
Sexually active participant should agree to use contraceptive methods throughout the treatment
Female participant should have a negative pregnancy test

Exclusion Criteria

If the participant or their legal guardian refuses to sign the informed consent form / consent term it will not be included in the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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