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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT00204568
Eligibility Criteria:
Inclusion Criteria:
* Histologically established metastatic (N+ or M1 = stage IV) or non-resectable soft tissue sarcoma·
* Grading II/III (Guillou et al. J Clin Oncol 1997)
* At least 1 measurable tumor parameter according to RECIST criteria
* Evidence of progression or primary manifestation (except osseous metastases and pleural effusion)
* No previous radiation therapy of the only measurable lesion
* No previous chemotherapy for metastatic disease; previous adjuvant chemotherapy is permitted if there was no progression of the disease within a period of 6 months
* Patients aged 60 years and beyond
* Written patient informed consent
* ECOG Status 0-2
* Granulocytes \>= 2 x 10\*\*9/l and thrombocytes \>= 100 x 10\*\*/l
* Serum creatinine, bilirubin \< 1.5 times the upper limit of normal value, albumin \> 25 g/l
* No severe comorbidity including psychosis or any previous history of uncontrolled cardiovascular disease
* Normal left-ventricular function by echocardiography or MUGA scan
* No symptomatic CNS metastases
* Willingness to receive regular follow-up examinations
Exclusion Criteria:
* Histological grading of malignancy: G I
* Histology of gastrointestinal stromal tumor, chondrosarcoma, uterine stromal sarcoma, mesothelioma, neuroblastoma, osteosarcoma, Ewing´s sarcoma/PNET, desmoplastic round cell tumor, embryonal rhabdomyosarcoma, alveolar soft tissue sarcoma
* Less than 5 years free of secondary malignancy except adequately treated carcinoma in situ (CIS) of the cervix, the bladder urothelium, basal cell carcinoma, or adenoma of the colon including pTIS, pTIN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00204568
Study Brief:
Protocol Section:
NCT00204568