Study with the aim to compare a chemotherapy based on low doses of oral cyclophosphamide administered daily vs standard doxorubicin in elderly patients with advanced soft tissue sarcomas.
- Conditions
- soft tissue sarcomasMedDRA version: 20.0Level: PTClassification code 10075333Term: Soft tissue sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001075-20-IT
- Lead Sponsor
- ISTITUTO ONCOLOGICO VENETO - IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 132
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>;Primary end point(s): time to treatment failure;Timepoint(s) of evaluation of this end point: every 8 weeks and at progression disease
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Progression free survival (PFS)<br>•Overall survival time (OS);<br>•Objective response rate (ORR);<br>; 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