New chemo cocktail shows promise for rare bone cancer
NCT ID NCT03011528
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a more intense chemotherapy plan for people aged 2 to 50 with Ewing sarcoma that has spread beyond the lungs. The goal was to see if this approach could help more patients become cancer-free for at least 18 months. The treatment combined high-dose chemotherapy with a stem cell transplant to try to control the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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45 people
The number who actually took part.
- Started
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Dec 2016
- Finished
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Nov 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. \- Ewing tumour histologically or cytologically confirmed, harboring a specific transcript, and with extrapulmonary metastases (including nodal extension) - histology and FISH results must be consistent, specific transcript can be obtained after inclusions. 2. \- Ewing tumour not previously treated. 3. \- Age between 2 and 50 years. 4. \- Measurable disease by cross sectional imaging (RECIST 1.1) or evaluable disease with functional metabolic, positron emission tomography scanner (PET SCAN) or other methods (e.g., cytology/histology). 5. \- General status compatible with the study treatments (LANSKY score ≥ 50%, or Karnofsky ≥ 50%, or Eastern Cooperative Oncology Group (ECOG) ≤ 2). 6. \- Adequate bone marrow function (not applicable in case of bone marrow disease). * Platelets ≥ 100 x 109 /L * Absolute Neutrophil Count (ANC) ≥ 1 x 109 /L * Hemoglobin ≥ 8g /dL. 7. \- Adequate liver function : * Aspartate Aminotransferase (AST) and Alanine Transferase (ALT) ≤ 5 x Upper Limit Normal (ULN) * Total Bilirubin ≤ 2 Upper Limit Normal (ULN). If total bilirubin \> 2xULN, Bilirubin Conjugated Fraction (BCF) ≤ 2 x ULN 8. \- No absolute contra-indication of Busulfan-Melphalan if radiotherapy of the primary tumour is necessary with specific attention to patient with primary spinal tumor. 9. \- Adequate cardiac and renal functions: * Creatinine \< 1.5 of normal for age or clearance \> 60 ml/min/1.73 m²; * Left Ventricular Ejection Fraction (LVEF) \> 50% and/or shortening fraction \> 28%. 10. \- No underlying disease contra-indicating the study treatments. 11. \- Patient likely compliant with the recommended study medical monitoring during and after treatments. 12. \- Patients of childbearing potential must agree to use adequate contraception for the duration of study treatments and up to 12 months for women and 6 months for men following completion of therapy. 13. \- Females of childbearing potential must have a negative serum β-human chorionic gonadotropin (HCG) pregnancy test within 10 days prior study inclusion, and/or urine pregnancy test within 48 hours before the first administration of the study treatment. 14. \- Patients covered by a health insurance system. 15. \- Patient, or patient's legal representative, informed and having signed the informed consent. Exclusion Criteria: 1. \- Age below 2 or greater than 50 years. 2. \- Ewing tumour localized, or solely with pleural and/or lung metastases. 3. \- Concomitant disease, particularly infectious disease, likely to interfere with patient's treatment. 4. \- History of cancer, according to investigator's judgment. 5. \- Life expectancy \< 2 months. 6. \- Patient already included in another clinical trial with an investigational drug. 7. \- Pregnant or breastfeeding patient. 8. \- Person deprived of liberty or under guardianship. 9. \- Patient likely unable to comply with the study medical monitoring for geographical, social or psychological reasons.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bordeaux Chu
Bordeaux, 33076, France
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CHRU Montpellier - Hôpital A. de Villeneuve
Montpellier, 34295, France
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CHU Grenoble Alpes
Grenoble, 38043, France
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CHU Hôpital Sud
Rennes, 35056, France
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Chr Felix Guyon
La Réunion, Saint Denis, 97400, France
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LILLE Centre Oscar Lambret
Lille, 59000, France
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LYON Centre Léon Bérard
Lyon, 69000, France
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Marseille Chu
Marseille, 13000, France
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NANCY Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
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Nancy Chu
Vandœuvre-lès-Nancy, 54511, France
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Nantes Chu
Nantes, 44000, France
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PARIS Institut Curie
Paris, 75005, France
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PARIS Trousseau
Paris, 75012, France
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Strasbourg Chu
Strasbourg, 67098, France
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TOULOUSE Institut Claudius Regaud
Toulouse, 31059, France
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Toulouse Chu
Toulouse, 31059, France
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VILLEJUIF Institut Gustave Roussy
Villejuif, 94805, France