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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2022 |
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Main ID: |
NCT02063022 |
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Date of registration:
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21/02/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma
EW-1 |
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Scientific title:
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Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma. |
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Date of first enrolment:
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January 22, 2009 |
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Target sample size:
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278 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02063022 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Roberto Luksch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Italian Sarcoma Group |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Ewing Sarcoma or PNET diagnosis centrally confirmed
- Age = 40 years
- Absence of evident metastasis or lung met < 0.5 cm Presence of skip metastasis in the
bone compartment of the primary tumor is to be considered as local disease and not
metastatic.
- Adeguate bone marrow, hepatic and renal function
- Left Ventricular Ejection Fraction > 50%
- No primary Ewing Sarcoma treatments (both chemotherapy and/or radiotherapy)
- Voluntarily signed an informed consent form
- Radiological and histological documentation available for central review.
Exclusion Criteria
- Presence of lung or extra-pulmonary lesions
- Bone Marrow involvement
- In case of chest disease: presence of plural effusion
- Elapsed time between histological diagnosis and chemotherapy start, more than 4 weeks
- Any medical contraindication to the use of the study drugs
- Any psychological or social conditions that can compromise the protocol compliance
and/or follow-up
- Previous malignancies (excluded in situ cervix carcinoma)
Age minimum:
N/A
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ewing's Sarcoma
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Intervention(s)
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Drug: Standard treatment (as per protocol ISG SSG III)
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Drug: Intensified chemotherapy
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Primary Outcome(s)
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Event Free Survival (EFS)
[Time Frame: 5 years]
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Secondary Outcome(s)
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Metastasis Free Survival
[Time Frame: expected average 2 years]
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Overall Survival (OS)
[Time Frame: expected average 5 years]
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Disease Free Survival (DFS)
[Time Frame: expected average 3 years]
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Secondary ID(s)
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ISG/AIEOP EW-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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