OSTEOSARCOMA
Conditions
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
Interventions
Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle
DRUGIfosfamide
Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle
Sponsors
Italian Sarcoma Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | at 6 months from randomization | Survival without progression of disease assessed at 6 months from randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 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 |
| Post treatment Surgery Rate | After 6, 12 and 18 weeks | Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles |
| Overall Response Rate | After 6, 12 and 18 weeks | Rate of tumor response assessed after cycle 2, 4 and 6 |
| Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments | After 6, 12 and 18 weeks and at 12 Months after end of treatment | Quality of Life evaluation related to received chemotherapy |
| Duration of hospitalization | 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 |
| Adverse Events Incidence | Every 3 weeks up to 22 weeks | Number and grade of adverse events related to the study treatments |
Countries
Italy
Outcome results
None listed