Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents|
- The rate of surgical resection necessity by progressing necrosis
|Study Start Date:||June 2001|
|Study Completion Date:||July 2003|
|Primary Completion Date:||July 2003 (Final data collection date for primary outcome measure)|
Accidental extravasation of anthracyclines including doxorubicin and its derivative epirubicin, may cause severe, progressive tissue necrosis requiring the surgical removal of any damaged tissue. Thus, the patient is subjected to major surgery causing substantial delay of the treatment of the primary cancer disease.
Tissue infiltration by anthracyclines may be detected by fluorescence microscopy. This test is performed at most hospitals in Denmark.
In a large preclinical trial, as well as 4 clinical cases, dexrazoxane has proven to prevent these severe tissue necroses. This trial will determine the effect of dexrazoxane as an acute treatment (acute antidote) in patients with anthracycline extravasation verified by fluorescence biopsy.
• To avoid surgical intervention following the accidental extravasation of anthracycline drug, and thus preventing the patient from sequelae.
- To avoid deleterious postponement of the cancer treatment itself.
- To evaluate and describe subjective and objective symptoms in the damaged area following treatment with TopotectTM.
- To evaluate tolerability/toxicity of TopotectTM used for this indication, according to the indicated schedule.
Trial Population 25 patients with accidental anthracycline extravasation confirmed by fluorescence microscopy
Trial Design Open-label clinical trial. Twenty-five consecutive patients with an acute (<6 hours) history of anthracycline extravasation confirmed by fluorescence microscopy (who in general practice are candidates for acute plastic surgical intervention) will be included.
Effect Variables Response rates, presence of late sequelae, time to progression, and clinical consequence of progression.
- Any toxicity caused by TopotectTM will be studied by blood tests, systematic questioning regarding subjective discomfort, as well as by objective clinical examination.
- A systematic clinical evaluation of the marked area of skin covering the area of extravasation will be performed to assure prompt treatment should any deterioration occur.
- Sequential colour photographs of the involved skin area will be taken.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548561
|Aalborg Hospital South|
|Aalborg, Denmark, 9100|
|Copenhagen, Denmark, 2100|
|Herlev County Hospital|
|Herlev, Denmark, 2730|
|Herlev Hospital Hematological Department|
|Herlev, Denmark, 2730|
|Herning District Hospital|
|Herning, Denmark, 7400|
|Hilleroed, Denmark, 3400|
|Odense University Hospital|
|Odense, Denmark, 5000 C|
|Roskilde County Hospital|
|Roskilde, Denmark, 4000|
|Viborg, Denmark, 8800|
|Principal Investigator:||Henning T Mouridsen, MD, Dr. med.||Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen|