OT APPLICABLE
- Conditions
- ON OPERABLE AND/OR METASTATIC SOFT TISSUE SARCOMASMedDRA version: 13.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2008-008922-55-PT
- Lead Sponsor
- Grupo Español de Investigación en Sarcomas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 182
The patient must sign voluntarily the informed consent
Aged between 18 and 70.
- Pathological diagnosis of non operable and/or metastatic soft tissue sarcoma.
- The following histological subtypes can be included:
•Undifferentiated pleomorphic sarcoma (previously, malignant fibrous histiocytoma)
•Leiomyosarcoma
•Angiosarcoma/ epithelial hemangioendothelioma
•Liposarcoma and its variants (well differentiated, dedifferentiated, myxoid/round cells, pleomorphic)
•Synovial sarcoma
•Fibrosarcoma and its variants ( epithelial fibrosarcoma/low grade fibromyxoid sarcoma)
•Hemangiopericytoma/solitary fibroid tumor
•Neurogenic sarcoma (Malignant peripheral nerve sheath tumor (MPNST))
•Mixofibrosarcoma
•Epithelioid Sarcoma
•Unclassified sarcoma (spindle cell/epithelioid/pleomorphic/myxoid)
- Measurable disease, according to RECIST criteria
- Performance status 0-1 (ECOG).
- Adequate bone marrow function (hemoglobin > 10 g/dL, leukocytes = 3.000/mm3, neutrophils = 1.500/mm3, platelets = 100.000/mm3). Patients with plasma creatinine = 1,6 mg/dL, transaminases = 2.5 times the UNL, total bilirubin = UNL, CPK = 2.5 times UNL, alkaline phosphatase = 2.5 times the UNL are acceptable. If the increase of alkaline phosphatase is > 2.5 times the UNL, then the alkaline phosphatase liver fraction and/or 5’ nucleotidase and/or GGT must be = UNL.
- Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.
- Normal cardiac function with a LVEF = 50% by echocardiogram or MUGA.
- It should be performed HBV and HCV serologies prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If the patient is HCV+ it could be included in the study if there are no changes in transaminases values at investigators' discretion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
Patients presenting with any of the following criteria cannot be included in the study:
- Previous chemotherapy treatment.
- Previous radiotherapy involving the only localization(s) of measurable tumoral disease.
- Performance status = 2 (ECOG).
- CNS metastases.
- Plasma bilirubin > UNL.
- Creatinine > 1.6 mg/dL.
- History of other neoplastic disease with the exception of basalioma or in situ cervical cancer adequately treated.
- Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
- Significant systemic diseases grade 3 or higher on the NCI-CTC version 3.0 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity.
- Uncontrolled bacterial, mycotic or viral infections.
- Known positive test for infection by human immunodeficiency virus (HIV)
- Women who are pregnant or breast-feeding
- Psychological, familial, social or geographic circumstances that limit the patient’s ability to comply with the protocol or informed consent.
- Patients participating in another clinical trial or receiving any other investigational product.
Patients who had participated in another clinical trial and/or had received any other investigational product in the last 30 days prior to inclusion.
- The following histologic subtypes are excluded:
- Rhabdomyosarcoma
-Ewing’s family of tumors
- Desmoplastic small round cell tumor
- Clear cell sarcoma
- Alveolar sarcoma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method