High risk localized soft tissue sarcomas typical of the adult MedDRA version: 9.1 Level: HLGT Classification code 10041299
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Epirubicin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Solution for in
Sponsors
ITALIAN SARCOMA GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Soft tissue sarcoma of adults, primary or locally recurrent, with spindle-cell or pleomorphic histology, belonging to one of the following for the randomization (Group1): ? Myxoid-Round Cell Liposarcomas (cellular componen t>5 %) ? Leiomyosarcoma ? Synovial sarcoma ? Malignant Peripheral Nerve Sheat Tumor ? Undifferentiated pleomorphic sarcoma (ex Malignant fibrous histiocytoma) Or belonging to one of the following for the registration (Group 2): ? Myxofibrosarcoma ? Unclassified Spindle Cell ? Pleomorphic Liposarcoma ? Pleomorphic Rabdomiosarcoma Or belonging to either group but not being evaluable for response (re-excision after previous inadequate resection or primary definitive surgery) (Group3) The histological diagnosis must be made according to the WHO criteria and will have to be centrally reviewed before randomization. 2) High malignancy grade: grade 3 of 3, according to Coindre, or grade 2 at biopsy with a radiological evidence of more than 50% of necrosis in the tumor mass. 3) Deep seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) lesion. 4) Size of primary tumor (visible or previously inadequately resected) >5 cm at instrumental staging (CT, MRI), or locally recurrent of any size. 5) Age > 18 years. 6) ECOG performance status 3.500/mm3 leukocytes >1.500/mm3 platelets >150.000/mm3 hemoglobin >11 g%. 8) Adequate renal (creatinine 2.5 x ULN, ALP LF and/or GGT = ULN) 9) Adequate cardiac function (FE >50%) 10) Signed informed consent. 11) Complete compliance of the participating center with the protocol requirements. 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
Exclusion criteria
Exclusion criteria: 1) Pregnancy or lactation. 2) Distant metastasis. 3) Other malignancies within past 5 years, with the exception of carcinoma in situ of cervix and basocellular skin cancers treated with eradicating intent. 4) Sarcoma histotypes other than those mentioned in the inclusion criteria. 5) Prior CT and/or RT. 6) Serious psychiatric disease that precludes informed consent or limits compliance. 7) Medical disease limiting survival to less than two years, limiting compliance or which in the physician’s opinion might interfere significantly with the toxicity of the treatments. 8) Cardiovascular diseases resulting in a New York Heart Association Functional Status >2. 9) Uncontrolled bacterial, viral or fungal infection. 10) Impossibility of ensuring adequate follow-up. 11) Failure to comply with the requirements of the present protocol leading to exclusion of the participating center.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the effect on disease-free survival of full-dose standard chemotherapy with histotype-tailored chemotherapy within the context of an integrated strategy for high risk soft tissue sarcomas typical of the adult.;Secondary Objective: - To compare the effect on overall survival of full-dose standard chemotherapy vs histotype-tailored chemotherapy - To compare the probability of response of standard vs histotype-tailored chemotherapy in the whole population receiving primary chemotherapy - To determine the objective response rate, as defined by RECIST criteria induced by preoperative full-dose standard chemotherapy vs tailored chemotherapy in each different histotype - To determine the pathological response rate induced by preoperative full-dose standard chemotherapy vs tailored chemotherapy in each different histotype - To study the feasibility of integration of preoperative chemotherapy with preoperative local-regional treatments (radiotherapy) - PET response.;Primary end point(s): To compare the effect on disease-free survival of full-dose standard chemotherapy with histotype-tailored chemotherapy within the context of an integrated strategy for high risk soft tissue sarcomas typical of the adult. | — |
Countries
Italy, Poland, Spain
Outcome results
None listed