Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT02587169
Eligibility Criteria:
Inclusion Criteria:
* Patients with histological diagnosis of well differentiated liposarcoma, dedifferentiated liposarcoma or primary leiomyosarcoma of retroperitoneum and resectable. In phase I the study will recruit patients with high-grade chondrosarcoma of non-mesenchymal type.
* Age: 18-70 years.
* Measurable disease, according to RECIST criteria.
* Functional status: 0-1 (ECOG).
* Baseline medullar function (hemoglobin \> 10 g/dL, leukocytes ≥ 3.000/mm3, RAN≥ 1,5 x 109 /l, granulocytes ≥ 1.500/mm3, platelets ≥ 100.000/mm3). Patients with alteration of transaminases ≤ 2.5 times the normal limits, bilirubin total ≤ LSN, CPK≤ 2.5 times the normal limits, alkaline phosphatase ≤ 2.5 times more the normal limits or creatinine values ≤ 1.6 mg/dL, are accepted.
* Cardiac function (LVEF) normal, considering the normal ranges of the institution.
* The patient must voluntarily sign the informed consent before any trial test, knowing that he/she can leave the trial at any time, without any consequence for his/her posterior medical attention.
* Patients in fertile age (both male and female) must use an effective contraceptive method before the entry in the study and during the trial. Moreover, women must maintain contraceptive measures up to 5 months after the treatment. Pregnancy must be ruled out though urine test (negative pregnancy test) for study enrolment.
Exclusion Criteria:
* Patients having received previous chemotherapy.
* Patient having been irradiated on the tumoral disease.
* Functional status \> 1 (ECOG).
* Metastasis in any location.
* Bilirubin values over the normal level. Creatinine over 1.6 mg/dL.
* History of another oncological disease except basalioma or in situ cervical carcinoma adequately treated.
* Serious cardiovascular diseases (dyspnea \>= 2 NYHA, ie.)
* Systemic pathologies limiting survival to less than 2 years, limiting patient availability, or those that, by clinical judgement, may interfere significantly with treatment toxicity.
* Bacterial, viral, or uncontrolled mycotic infectious diseases.
* Pregnant or lactating patients.
* Psychological, family, sociological or geographical situations not allowing protocol fulfilment or informed consent signature.
* Patients currently involved in other clinical trials receiving any other agent under investigation.
* Patient having participated in a clinical trial and/or having received an agent under investigation in the 30 days prior to enrolment.
* Patients requiring treatments with prolongation of QT interval as amiodarone, disopyramide, procainamide, quinidine, and sotalol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02587169
Study Brief:
Protocol Section:
NCT02587169