Phase II Trial for the Treatment of Relapsed Osteosarcoma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02718482
• Date of registration: 02/03/2016
• Prospective Registration: Yes
• Primary sponsor: Italian Sarcoma Group
• Public title: Phase II Trial for the Treatment of Relapsed Osteosarcoma OsteoREC2015
• Scientific title: Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma
• Date of first enrolment: April 6, 2016
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02718482
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Stefano Ferrari, MD
• Affiliation: Istituto Ortopedico Rizzoli

Key inclusion & exclusion 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



Age minimum: 4 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

OSTEOSARCOMA

Intervention(s)

Drug: Ifosfamide

Drug: Gemcitabine and Docetaxel

Primary Outcome(s)

Progression Free Survival [Time Frame: at 6 months from randomization]

Secondary Outcome(s)

Overall Response Rate [Time Frame: After 6, 12 and 18 weeks]

Overall Survival [Time Frame: At patient death or at last available follow-up]

Adverse Events Incidence [Time Frame: Every 3 weeks up to 22 weeks]

Duration of hospitalization [Time Frame: After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks]

Post treatment Surgery Rate [Time Frame: After 6, 12 and 18 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]

Secondary ID(s)

OsteoREC2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors