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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00548704
Eligibility Criteria:
Inclusion Criteria:
1. All cancer patients treated with anthracyclines
2. Informed consent must be obtained from the patient
3. Patients suspected to have been exposed to extravasation (leakage) of anthracycline, defined as:
1. A primary assessment by the physician on duty, which would activate the standard departmental procedure for treatment of anthracycline extravasation.
2. The presence of at least one of the following symptoms: pain, swelling or redness at the site where the anthracycline leakage is suspected to have occurred.
4. Suspicion of anthracycline extravasation from a central venous access device
5. The Topotect® infusion must be started \< 6 hours after the accident
6. 18 years of age or older
7. Performance status (PS) \< 2
Exclusion Criteria:
1. Known allergy towards dexrazoxane
2. Reasonable suspicion of extravasation by other compounds than anthracyclines through the same intravenous access, e.g. vincristine, mitomycin, and vinorelbine, all of which may cause ulceration
3. AST (aspartate aminotransferase) or ALT (alanine aminotransferase), bilirubin, LDH (lactate dehydrogenase), alkaline phosphatase \>3 x upper normal value
4. Neutrophils CTC (common toxicity criteria) ≥ grade 2. (neutrophils 1.5 x 109/L, ≥1,500/mm3)
5. Platelets CTC ≥ grade 2. (platelets ≥75.0 x 109/L, \<75,000/mm3).
6. Topical use of DMSO (dimethylsulfoxide) at the area of the accident
7. Administration of dexrazoxane within the last 3 weeks
8. Pregnant or nursing women
9. Women of childbearing age and potential, who do not use an efficient contraceptive (e.g. the Pill or a diaphragm plus a spermicide) for at least 3 months prior to the start of trial medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00548704
Study Brief:
Protocol Section:
NCT00548704