soft tissue sarcomas MedDRA version: 20.0 Level: PT Classification code 10075333 Term: Soft tissue sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ENDOXAN BAXTER - 50 MG COMPRESSE RIVESTITE 50 COMPRESSE
Product Name: Ciclofosfamidde
Product Code: [Ciclofosfamide]
Pharmaceutical Form: Coated tablet
CAS Number: 50-18-0
Current Sponsor
Sponsors
ISTITUTO ONCOLOGICO VENETO - IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in the study only if they meet all the following criteria: 1- Histologically proven diagnosis of soft tissue sarcoma. 2- Advanced unresectable or metastatic soft tissue sarcoma not previously treated with chemotherapy for metastatic disease. 3- At least one measurable lesion according to RECIST1.1 criteria. 4- Availability of a tumor sample 5- Age = 70 years 6- ECOG PS 0-2. 7- Life expectancy of at least 12 weeks. 8- Neutrophils =1.5 x 109/L, Platelets =100 x 109/L, Hgb = 9 g/dl. 9- Normal hepatic, renal anf cardiac function. 10- Male subjects with female partners of childbearing potential must be willing to use adequate contraception. 11- Geriatric assessment by means of G8 screening tool and CRASH score. 12- Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 132
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study for any of the following reasons: 1- Previous treatment for metastatic disease. 2- Previous (neo) adjuvant chemotherapy with anthracyclines. 3- Radiotherapy to any site within 4 weeks before the study. 4- Untreated brain metastases or spinal cord compression or primary brain tumors. 5- Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration. 6- Clinically significant cardiovascular disease 7- Treatment with any investigational drug within 30 days prior to enrollment or 2 investigational agent half-lives (whichever is longer) 8- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ. 9- Lack of physical integrity of the upper gastrointestinal tract, . 10- Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs. 11- Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies. 12- Sexually active males unwilling to practice contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the efficacy, as measured by time to treatment failure, of metronomic cyclophosphamide compared to doxorubicin in elderly patients affected by mSTS. ;Secondary Objective: Efficacy, Toxicity profile and to explore other possible predictive or prognostic factors and their interaction with treatment arms. ;Primary end point(s): time to treatment failure;Timepoint(s) of evaluation of this end point: every 8 weeks and at progression disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival (PFS) • Overall survival time (OS); • Objective response rate (ORR); ; Toxicity profile; Traslarional research;Timepoint(s) of evaluation of this end point: every 8 weeks and at PD ; Time from the signing of the IC to 30 days after the end of the treatment, and at PD; At the screening | — |
Countries
Italy
Contacts
Public ContactUnità di ricerca Clinica - Istituto
Istituto Oncologico Veneto
Outcome results
None listed