Phase II Trial for the Treatment of Relapsed Osteosarcoma (OsteoREC2015)

May 9, 2019 updated by: Italian Sarcoma Group

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
      • Firenze, Italy, 50139
        • A.O. Universitaria Meyer
      • Genova, Italy
        • Istituto Giannina Gaslini
      • Milano, Italy
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Napoli, Italy, 80100
        • Università seconda di Napoli
      • Padova, Italy
        • Azienda Ospedaliera Di Padova
      • Rome, Italy, 00100
        • Istituto Regina Elena - IFO
      • Torino, Italy, 10126
        • Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
    • TO
      • Torino, TO, Italy, 10153
        • Ospedale Gradenigo
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
Drug: Ifosfamide
Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle
Other Names:
  • High doses ifosfamide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: at 6 months from randomization
Survival without progression of disease assessed at 6 months from randomization
at 6 months from randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: After 6, 12 and 18 weeks
Rate of tumor response assessed after cycle 2, 4 and 6
After 6, 12 and 18 weeks
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
At patient death or at last available follow-up
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
After 6, 12 and 18 weeks
Adverse Events Incidence
Time Frame: Every 3 weeks up to 22 weeks
Number and grade of adverse events related to the study treatments
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
Quality of Life evaluation related to received chemotherapy
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
Number of days spent in hospital related to treatment received
After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Italian Sarcoma Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefano Ferrari, MD, Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OsteoREC2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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