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

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

7

Phase

  • 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

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
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
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

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

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

Italian Sarcoma Group

Investigators

  • 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)

April 6, 2016

Primary Completion (Actual)

January 7, 2019

Study Completion (Actual)

January 7, 2019

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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