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Phase II Trial of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma - EORTC-1202

Studio Clinico

Patologia: Sarcomi dei tessuti molli e gist

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Local diagnosis of dedifferentiated liposarcoma
- Age 18-75 yrs
- WHO performance status 0-1
- Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months
- Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.1.
- One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved).
- Adequate haematological, renal and hepatic function
- Birth control measures
- Estimated life expectancy > 3 months
- Related adverse events from previous therapies ≤ Grade 1
- Written informed consent

Criteri di esclusione: 

- More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization.
- Symptomatic CNS metastases
- Previous encephalopathy of any cause or other significant neurological condition
- Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
- Pregnancy
- Inflammation of the urinary bladder (cystitis)
- Other invasive malignancy within 5 years (exceptions of non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treated basal or squamous cell skin carcinoma)
- Significant cardiac disease
- Uncontrolled severe illness or medical condition, other than DD liposarcoma
- Hypersensitivity to taxanes or their excipients

Trattamento sperimentale: 

cabazitaxel

Trattamento di controllo: 

/

Obiettivi primari dello studio: 

Progression free survival (PFS) [Time Frame: 3 years from first patient in
The primary endpoint will be progression free survival, assessed at 12 weeks after start of treatment

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

Riferimento: Prof. Paolo Casali
Telefono: 0223902803
Email: paolo.casali@istitutotumori.mi.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

Riferimento: Dr. Umberto Basso
Telefono: 0498215953
Email: umberto.basso@iov.veneto.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2012-003672-39

Data di inserimento: 10.09.2018

Promotore

European Organisation for Research and Treatment of Cancer - EORTC

CRO

NA

Principal Investigator ITALIA

Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano

Riferimento: Prof. Paolo Casali

Telefono: 0223902803

Email: paolo.casali@istitutotumori.mi.it

Localita: Milano

 

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