OsteosarcomaPhase 2GLATO2017NCT03063983
Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma
A Phase 2 study testing Cyclophosphamide and Methotrexate in people with Osteosarcoma, run by Grupo de Apoio ao Adolescente e a Crianca com Cancer at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 30 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Cyclophosphamide and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2017to 31 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- If the participant or their legal guardian refuses to sign the informed consent form / consent term it will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Grupo de Apoio ao Adolescente e a Criança com Câncer
São Paulo, São Paulo, 04039001
Antonio S Petrilli, +55 (11) 5080-8400, sergiopetrilli@graacc.org.br
Andreza A Senerchia, +55 (11) 5080-8400, andrezasenerchia@graacc.org.br
About this study
Official title: A Study Multicenter Randomized to Assess the Efficacy and Toxicity of Adding Metronomic Therapy to the Standard Treatment of Patients With High Grade Malignant Osteosarcoma With Metastatic Lung Disease at Diagnosis and Primary Resectable Tumor: A Study by the Latin American Group for Treatment of Osteosarcoma
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
Read the detailed 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).
- Conditions
- Osteosarcoma
- Being tested
- Cyclophosphamide, Methotrexate
- Keywords
- osteosarcoma, metastatic, metronomic therapy
- Medical subject headings
- Osteosarcoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Continuous oral cyclophosphamide
MethotrexateDrug
Continuous oral methotrexate
| Study group | Role | What they receive |
|---|---|---|
| Maintenance therapy | Experimental | 104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP Receives: Drug: Cyclophosphamide; Drug: Methotrexate |
| Control | No intervention | 31 weeks of MAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and toxicity of adding metronomic therapy in disease event-free survival.
To assess the impact of adding metronome therapy to the standard treatment of patients with resectable end-stage osteosarcoma and metastatic lung disease in event-free survival.
Measured: Five years
Secondary outcomes (3)
Efficacy and toxicity of adding metronomic therapy in overall survival
To evaluate the impact of the addition of metronomic therapy to the standard treatment of patients with end-resectable osteosarcoma and metastatic lung disease in overall survival.
Measured: Five years
Cardiotoxicity (occurrence of cardiotoxicity)
To compare the occurrence of cardiotoxicity with the addition of dexrazoxane since the first cycle of doxorubicin with the findings of the previous study (GLATO 2006).
Measured: Five years
Immunohistochemistry (expression of VEGF)
Immunohistochemistry the expression of VEGF in the biopsy, primary tumor and metastases
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start2 Jan 2017
- Primary completion2 Jan 2019 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Apoio ao Adolescente e a Crianca com Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antônio Sérgio Petrilli, Grupo de Apoio ao Adolescente e a Crianca com Cancer
- Investigators
- Cláudia F Fontes, Study chair, Grupo de Apoio ao Adolescente e a Crianca com Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063983
- Sponsor's protocol ID
- GLATO2017
- Acronym
- GLATO2017
- Status last verified
- Mar 2017
- First submitted
- 27 Jan 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Multicenter Randomized to Assess the Efficacy and Toxicity of Adding Metronomic Therapy to the Standard Treatment of Patients With High Grade Malignant Osteosarcoma With Metastatic Lung Disease at Diagnosis and Primary Resectable Tumor: A Study by the Latin American Group for Treatment of Osteosarcoma
- ClinicalTrials.gov ID
- NCT03063983
- Acronym / sponsor ID
- GLATO2017 / GLATO2017
- Conditions
- Osteosarcoma
- Keywords
- osteosarcoma, metastatic, metronomic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Grupo de Apoio ao Adolescente e a Crianca com CancerUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 2 Jan 2019 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance therapy | Experimental | Drug: Cyclophosphamide, Drug: Methotrexate104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP |
| Control | No intervention | –31 weeks of MAP |
Who may qualify
- Ages
- 1 day to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- If the participant or their legal guardian refuses to sign the informed consent form / consent term it will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideContinuous oral cyclophosphamide | Drug | Maintenance therapy |
| MethotrexateContinuous oral methotrexate | Drug | Maintenance therapy |
Primary outcome
Efficacy and toxicity of adding metronomic therapy in disease event-free survival.
Time frame: Five years
To assess the impact of adding metronome therapy to the standard treatment of patients with resectable end-stage osteosarcoma and metastatic lung disease in event-free survival.
3 secondary outcomes
Efficacy and toxicity of adding metronomic therapy in overall survival
Time frame: Five years
Cardiotoxicity (occurrence of cardiotoxicity)
Time frame: Five years
Immunohistochemistry (expression of VEGF)
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Osteosarcoma
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Pediatric Osteosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cláudia F Fontes study chair
Grupo de Apoio ao Adolescente e a Crianca com Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide and Methotrexate in people with Osteosarcoma, run by Grupo de Apoio ao Adolescente e a Crianca com Cancer at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio S Petrilli (+55 (11) 5080-8400, sergiopetrilli@graacc.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and toxicity of adding metronomic therapy in disease event-free survival. (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.