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

Primary Purpose

OSTEOSARCOMA

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Gemcitabine and Docetaxel
Ifosfamide
Sponsored by
Italian Sarcoma Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OSTEOSARCOMA

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo
  • Ospedale Gradenigo
  • Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
  • A.O. Universitaria Meyer
  • Istituto Giannina Gaslini
  • FONDAZIONE IRCCS Istituto Nazionale dei Tumori
  • Università seconda di Napoli
  • Azienda Ospedaliera di Padova
  • Istituto Regina Elena - IFO
  • Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gemcitabine and Docetaxel

Ifosfamide

Arm 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

Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks

Outcomes

Primary Outcome Measures

Progression Free Survival
Survival without progression of disease assessed at 6 months from randomization

Secondary Outcome Measures

Overall Response Rate
Rate of tumor response assessed after cycle 2, 4 and 6
Overall Survival
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
Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles
Adverse Events Incidence
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
Quality of Life evaluation related to received chemotherapy
Duration of hospitalization
Number of days spent in hospital related to treatment received

Full Information

First Posted
March 2, 2016
Last Updated
May 9, 2019
Sponsor
Italian Sarcoma Group
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1. Study Identification

Unique Protocol Identification Number
NCT02718482
Brief Title
Phase II Trial for the Treatment of Relapsed Osteosarcoma
Acronym
OsteoREC2015
Official Title
Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Not adequate enrollment (sample size not possible to reach)
Study Start Date
April 6, 2016 (Actual)
Primary Completion Date
January 7, 2019 (Actual)
Study Completion Date
January 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Italian Sarcoma Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSTEOSARCOMA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Ferrari, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale Gradenigo
City
Torino
State/Province
TO
ZIP/Postal Code
10153
Country
Italy
Facility Name
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
A.O. Universitaria Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Istituto Giannina Gaslini
City
Genova
Country
Italy
Facility Name
FONDAZIONE IRCCS Istituto Nazionale dei Tumori
City
Milano
Country
Italy
Facility Name
Università seconda di Napoli
City
Napoli
ZIP/Postal Code
80100
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
Istituto Regina Elena - IFO
City
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Name
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
7850705
Citation
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.
Results Reference
background
PubMed Identifier
8464555
Citation
Bacci 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.
Results Reference
background
PubMed Identifier
11821461
Citation
Bielack 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.
Results Reference
background
PubMed Identifier
20589638
Citation
Meazza 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.
Results Reference
background

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Phase II Trial for the Treatment of Relapsed Osteosarcoma

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