Status:
COMPLETED
Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma
Lead Sponsor:
Italian Sarcoma Group
Collaborating Sponsors:
Istituto Di Ricerche Farmacologiche Mario Negri
Conditions:
Liposarcoma
Leiomyosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison end point. This study aims at confirming the activity of the drug trabectedin as second/further line treat...
Detailed Description
Retroperitoneal soft-tissue sarcomas (R-STSs) are rare neoplasms, accounting for 10% to 15% of Soft Tissue Sarcomas (STSs), which represent 1-3% of all cancers. They may show different histological ty...
Eligibility Criteria
Inclusion
- Persistent or locally relapsed and/or metastatic disease (in case of local disease, surgery may be technically feasible or not, but the clinical judgment must be that medical therapy is indicated)
- Pathology specimens available for centralized review
- Age ≥ 18 years
- European Eastern Cooperative Oncology Group Personal Status (ECOG PS) ≤ 2
- One or more previous systemic treatments employing anthracyclines and ifosfamide (unless one or both are clinically contraindicated)
- Measurable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST)
- A minimum of 3 weeks since any previous medical therapy
- Recovery from toxic effects of prior therapies to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 1 or lower
- Adequate haematological, renal and liver functions
- Ability and willingness to provide informed consent
Exclusion
- Pregnant or breast-feeding women
- Prior exposure to trabectedin
- Peripheral neuropathy, Grade 2 or higher
- History of other malignancies (except for basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse
- Known central nervous system (CNS) metastases
- Active viral hepatitis or chronic liver disease
- Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias
- Active major infection
- Other serious concomitant illnesses
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2019
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02247544
Start Date
March 1 2014
End Date
March 12 2019
Last Update
November 1 2021
Active Locations (21)
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1
Istituto Tumori Giovanni Paolo II
Bari, BA, Italy, 70124
2
Azienda Ospedaliera Giovanni Paolo XXIII
Bergamo, BG, Italy, 24127
3
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, BO, Italy, 40138
4
A.O. Spedali Civili
Brescia, BS, Italy, 25123