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:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT00204620
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed metastatic or non-resectable soft tissue sarcoma
* Evidence of progression or relapse after an anthracycline-based and/ or ifosfamide-based chemotherapy
* At least 1 bidimensionally measurable tumor lesion according to RECIST criteria
* No previous radiation therapy on the only measurable lesion
* Willingness to receive regular follow-up
* Life expectancy more than 3 months
* ECOG status \>= 2
* Patients aged 18 years and beyond
* leucocytes \> 2500/µl, thrombocytes \> 75000/µl)
* Serum creatine \< 1,5 times the upper limit of normal value, GFR \> 60/ml
* Written patient informed consent
* Ability to give informed consent
Exclusion Criteria:
* Previous or concurrent radiation of the index lesion (radiation of single lesion is allowed if not the index lesion)
* Insufficient liver function (bilirubin \> 1.5 the upper limit of normal, prolongation of PT and aPTT \> 1.5 the upper limit of normal; ASAT and ALAT \> 3 the upper limit of normal (patients with liver metastases ASAT and ALAT \> 5 the upper limit of normal)
* Active infection
* Prior therapy with Bendamustin hydrochloride
* Prior malignancies (other than adequately treated carcinoma in situ (CIS) of the cervix, bladder urothelium, basal cell carcinoma or adenoma of the colon including pTIS,pTIN), unless treated with curative intent and without evidence of disease \> 5 years
* Symptomatic cardio- and/or cerebrovascular disease (NYHA-Scale III°)
* Interval since last chemotherapy \< 4 weeks
* Evidence of CNS-metastases
* Evidence of pregnancy or lactation
* Woman of child-bearing potential without reliable methods of birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00204620
Study Brief:
Protocol Section:
NCT00204620