Clinical trial · Interventional
Phase II Trial for the Treatment of Relapsed Osteosarcoma
Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma
NCT02718482CI-TRIAL-00038575OsteoREC2015terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not adequate enrollment (sample size not possible to reach)
Summary
Brief summary (as posted)
Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| OSTEOSARCOMA | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine and Docetaxel | Drug | — | UNRESOLVED |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine and Docetaxel
- description
- Gemcitabine i.v. 900 mg/m2 in 30 min on day 1 and day 8 every 3 weeks Docetaxel i.v. 75 mg/m2 in 60 min on day 8 every 3 weeks
- interventionNames
- Drug: Gemcitabine and Docetaxel
- type
- EXPERIMENTAL
- label
- Ifosfamide
- description
- Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks
- interventionNames
- Drug: Ifosfamide
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- at 6 months from randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of high grade osteosarcoma recurrence * Resectable or unresectable recurrence disease within 24 months from the initial diagnosis * Pleuro-pulmonary recurrence with more than 2 nodules within 24 months from the initial diagnosis * Unresectable first relapse within 24 months from the initial diagnosis * Resectable or unresectable second of further recurrence of high grade osteosarcoma * Age at diagnosis at least 4years. * Karnofsky performance status over 60%. * Renal function and hepatic In normal limits for age. * L eft ejection ventricular fraction over 50%. * White blood cells over 3000 million/liter and platelets 100000 million/liter * Birth potential female must agreed to contraception * Signed written informed consent Exclusion Criteria: * Contraindication to the use of any study drugs * Mental, social and geographic conditions which fail to ensure adequate adherence to the study * Hepatitis and human immunodeficiency virus active infection * Pregnancy or breast-feeding * Previous treatment with Gemcitabine, Docetaxel and Ifosfamide
References
Publications (4)
- BACKGROUNDSaeter G, Hoie J, Stenwig AE, Johansson AK, Hannisdal E, Solheim OP. Systemic relapse of patients with osteogenic sarcoma. Prognostic factors for long term survival. Cancer. 1995 Mar 1;75(5):1084-93. doi: 10.1002/1097-0142(19950301)75:53.0.co;2-f. PMID 7850705
- BACKGROUNDBacci G, Briccoli A, Ferrari S, Ruggieri P, Avella M, Casadei R, Battistini A, Picci P. [Osteosarcoma of the extremities metastatic at presentation. Results obtained with primary chemotherapy followed by simultaneous resection of the primary and metastatic lesion]. Minerva Chir. 1993 Jan;48(1-2):35-45. Italian. PMID 8464555
- BACKGROUNDBielack SS, Kempf-Bielack B, Delling G, Exner GU, Flege S, Helmke K, Kotz R, Salzer-Kuntschik M, Werner M, Winkelmann W, Zoubek A, Jurgens H, Winkler K. Prognostic factors in high-grade osteosarcoma of the extremities or trunk: an analysis of 1,702 patients treated on neoadjuvant cooperative osteosarcoma study group protocols. J Clin Oncol. 2002 Feb 1;20(3):776-90. doi: 10.1200/JCO.2002.20.3.776. PMID 11821461
- BACKGROUNDMeazza C, Casanova M, Luksch R, Podda M, Favini F, Cefalo G, Massimino M, Ferrari A. Prolonged 14-day continuous infusion of high-dose ifosfamide with an external portable pump: feasibility and efficacy in refractory pediatric sarcoma. Pediatr Blood Cancer. 2010 Oct;55(4):617-20. doi: 10.1002/pbc.22596. PMID 20589638