OSTEOSARCOMAPhase 2OsteoREC2015NCT02718482
Phase II Trial for the Treatment of Relapsed Osteosarcoma
A Phase 2 study testing Gemcitabine and Docetaxel and Ifosfamide in people with OSTEOSARCOMA, run by Italian Sarcoma Group at 10 sites in Italy.
Trial summary
Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- OSTEOSARCOMA
- What is being tested?
- Gemcitabine and Docetaxel and Ifosfamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 10 sitesItaly
- Study dates
- 6 Apr 2016to 7 Jan 2019
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, 40136
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, 10060
A.O. Universitaria Meyer
Florence, 50139
Istituto Giannina Gaslini
Genova
FONDAZIONE IRCCS Istituto Nazionale dei Tumori
Milan
Università seconda di Napoli
Naples, 80100
Azienda Ospedaliera di Padova
Padova
Istituto Regina Elena - IFO
Rome, 00100
Ospedale Gradenigo
Torino, TO, 10153
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, 10126
About this study
Official title: Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma
Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma
Read the detailed description
Patients with relapsed osteosarcoma will be randomized to receive Gemcitabine plus Docetaxel or High Doses Ifosfamide (continuous infusion) every 3 weeks, up to 6 weeks
- Conditions
- OSTEOSARCOMA
- Being tested
- Gemcitabine and Docetaxel, Ifosfamide
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine and DocetaxelDrug
Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle
IfosfamideDrug
Also called High doses ifosfamide
Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine and Docetaxel | Experimental | 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 Receives: Drug: Gemcitabine and Docetaxel |
| Ifosfamide | Experimental | Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks Receives: Drug: Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Survival without progression of disease assessed at 6 months from randomization
Measured: at 6 months from randomization
Secondary outcomes (6)
Overall Response Rate
Rate of tumor response assessed after cycle 2, 4 and 6
Measured: After 6, 12 and 18 weeks
Overall Survival
From date of starting therapy until the date of death from any cause, whichever came first, assessed up to 60 months
Measured: At patient death or at last available follow-up
Post treatment Surgery Rate
Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles
Measured: After 6, 12 and 18 weeks
Adverse Events Incidence
Number and grade of adverse events related to the study treatments
Measured: Every 3 weeks up to 22 weeks
Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments
Quality of Life evaluation related to received chemotherapy
Measured: After 6, 12 and 18 weeks and at 12 Months after end of treatment
Duration of hospitalization
Number of days spent in hospital related to treatment received
Measured: After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start6 Apr 2016
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
Why it stopped: Not adequate enrollment (sample size not possible to reach)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italian Sarcoma Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Stefano Ferrari, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718482
- Sponsor's protocol ID
- OsteoREC2015
- Acronym
- OsteoREC2015
- Status last verified
- May 2019
- First submitted
- 2 Mar 2016
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Saeter 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.
PubMed 7850705Bacci 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.
PubMed 8464555Bielack 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.
PubMed 11821461Meazza 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.
PubMed 20589638
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma
- ClinicalTrials.gov ID
- NCT02718482
- Acronym / sponsor ID
- OsteoREC2015 / OsteoREC2015
- Conditions
- OSTEOSARCOMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not adequate enrollment (sample size not possible to reach)
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Italian Sarcoma GroupResearch network
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma
Detailed description
Patients with relapsed osteosarcoma will be randomized to receive Gemcitabine plus Docetaxel or High Doses Ifosfamide (continuous infusion) every 3 weeks, up to 6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine and Docetaxel | Experimental | Drug: Gemcitabine and DocetaxelGemcitabine 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 |
| Ifosfamide | Experimental | Drug: IfosfamideIfosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Gemcitabine and DocetaxelTreatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle | Drug | Gemcitabine and Docetaxel |
| IfosfamideAlso: High doses ifosfamideTreatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle | Drug | Ifosfamide |
Primary outcome
Progression Free Survival
Time frame: at 6 months from randomization
Survival without progression of disease assessed at 6 months from randomization
6 secondary outcomes
Overall Response Rate
Time frame: After 6, 12 and 18 weeks
Overall Survival
Time frame: At patient death or at last available follow-up
Post treatment Surgery Rate
Time frame: After 6, 12 and 18 weeks
Adverse Events Incidence
Time frame: Every 3 weeks up to 22 weeks
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
Duration of hospitalization
Time frame: After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks
Results and safety
The study was stopped early (reason given: Not adequate enrollment (sample size not possible to reach)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Background: PubMed 7850705Saeter 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.
- Background: PubMed 8464555Bacci 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.
- Background: PubMed 11821461Bielack 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.
- Background: PubMed 20589638Meazza 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.
- Individual participant dataSharing planned: Yes
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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.
Stefano Ferrari, MD principal investigator
Istituto Ortopedico Rizzoli
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and Docetaxel and Ifosfamide in people with OSTEOSARCOMA, run by Italian Sarcoma Group at 10 sites in Italy.
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 12 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. 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?
The study was stopped early (reason given: Not adequate enrollment (sample size not possible to reach)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: at 6 months from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02718482, which also lists 4 linked publications.
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 May 2019.