Anthracycline Extravasation Clinical Trial
Official title:
A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.
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.
Purpose
Primary:
• To avoid surgical intervention following the accidental extravasation of anthracycline
drug, and thus preventing the patient from sequelae.
Secondary:
- 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.
Safety Features
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment