Trials / Terminated
TerminatedNCT04656262
Low Dose Continuous Cyclophosphamide vs Standard Doxorubicin in Advanced Sarcoma Elderly Patients
The METROPHOLYS Study Metronomic Cyclophosphamide vs Doxorubicin in Elderly Patients With Advanced Soft Tissue Sarcomas Randomized, Controlled Open Label Clinical Trial
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Istituto Oncologico Veneto IRCCS · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
Summary
To compare the efficacy, as measured by time to treatment failure, of metronomic cyclophosphamide with respect to doxorubicin in elderly patients affected by mSTS.
Detailed description
This phase III randomized clinical trial was designed to compare metronomic Cyclophosphamide with standard Doxorubicin for the first-line treatment of elderly cancer patients with advanced inoperable or metastatic STS: i) ARM A (experimental): Metronomic Cyclophosphamide ii) ARM B (control): Doxorubicin up to six cycles
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclophosphamide | Cyclophosphamide is formulated as coated tablets of 50mg for oral administration |
| DRUG | Doxorubicin | Doxorubicin is formulated as 60 mg/mq for infusional use (i.v use) |
Timeline
- Start date
- 2018-09-10
- Primary completion
- 2024-05-23
- Completion
- 2024-05-23
- First posted
- 2020-12-07
- Last updated
- 2024-07-08
Locations
13 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT04656262. Inclusion in this directory is not an endorsement.