Phase II Trial for the Treatment of Relapsed Osteosarcoma (OsteoREC2015)
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ClinicalTrials.gov Identifier: NCT02718482 |
Recruitment Status :
Terminated
(Not adequate enrollment (sample size not possible to reach))
First Posted : March 24, 2016
Last Update Posted : May 13, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
OSTEOSARCOMA | Drug: Gemcitabine and Docetaxel Drug: Ifosfamide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma |
Actual Study Start Date : | April 6, 2016 |
Actual Primary Completion Date : | January 7, 2019 |
Actual Study Completion Date : | January 7, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Gemcitabine and Docetaxel
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
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Drug: Gemcitabine and Docetaxel
Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle |
Experimental: Ifosfamide
Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks
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Drug: Ifosfamide
Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle
Other Name: High doses ifosfamide |
- Progression Free Survival [ Time Frame: at 6 months from randomization ]Survival without progression of disease assessed at 6 months from randomization
- Overall Response Rate [ Time Frame: After 6, 12 and 18 weeks ]Rate of tumor response assessed after cycle 2, 4 and 6
- Overall Survival [ Time Frame: At patient death or at last available follow-up ]From date of starting therapy until the date of death from any cause, whichever came first, assessed up to 60 months
- Post treatment Surgery Rate [ Time Frame: After 6, 12 and 18 weeks ]Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles
- Adverse Events Incidence [ Time Frame: Every 3 weeks up to 22 weeks ]Number and grade of adverse events related to the study treatments
- Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments [ Time Frame: After 6, 12 and 18 weeks and at 12 Months after end of treatment ]Quality of Life evaluation related to received chemotherapy
- Duration of hospitalization [ Time Frame: After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks ]Number of days spent in hospital related to treatment received

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 4 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718482
Italy | |
Fondazione del Piemonte per l'Oncologia IRCC Candiolo | |
Candiolo, Torino, Italy, 10060 | |
Ospedale Gradenigo | |
Torino, TO, Italy, 10153 | |
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors | |
Bologna, Italy, 40136 | |
A.O. Universitaria Meyer | |
Firenze, Italy, 50139 | |
Istituto Giannina Gaslini | |
Genova, Italy | |
FONDAZIONE IRCCS Istituto Nazionale dei Tumori | |
Milano, Italy | |
Università seconda di Napoli | |
Napoli, Italy, 80100 | |
Azienda Ospedaliera di Padova | |
Padova, Italy | |
Istituto Regina Elena - IFO | |
Rome, Italy, 00100 | |
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology | |
Torino, Italy, 10126 |
Principal Investigator: | Stefano Ferrari, MD | Istituto Ortopedico Rizzoli |
Responsible Party: | Italian Sarcoma Group |
ClinicalTrials.gov Identifier: | NCT02718482 |
Other Study ID Numbers: |
OsteoREC2015 |
First Posted: | March 24, 2016 Key Record Dates |
Last Update Posted: | May 13, 2019 |
Last Verified: | May 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Gemcitabine Docetaxel Ifosfamide Isophosphamide mustard Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Alkylating Alkylating Agents |