NCT00548561

Brief Summary

The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2001

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
Last Updated

October 21, 2015

Status Verified

November 1, 2013

Enrollment Period

2.1 years

First QC Date

October 23, 2007

Last Update Submit

October 20, 2015

Conditions

Anthracycline Extravasation

Keywords

extravasationanthracyclines

Outcome Measures

Primary Outcomes (1)

  • The rate of surgical resection necessity by progressing necrosis

Interventions

DexrazoxaneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer patients treated with anthracycline
  • Informed consent obtained from the patient.
  • Suspicion of anthracycline extravasation is defined as:
  • A primary assessment by the physician on duty, which would activate the standard departmental procedure for treatment of anthracycline extravasation.
  • The presence of at least one of the following:
  • pain
  • swelling
  • redness
  • The Topotect infusion must be started \<6 hours after the accident.
  • The patient must be at least 18 years of age.
  • Performance status (PS) ≤2.
  • Suspicion of anthracycline extravasation from a central venous access device. -

You may not qualify if:

  • Known allergy towards dexrazoxane.
  • 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.
  • AST, ALT, bilirubin, LDH, serum alkaline phosphatase \>3 x upper normal value
  • Neutropenia and thrombocytopenia ≥ CTC grade 2
  • Pregnant or nursing women
  • Women of childbearing age and potential, where the patient does not agree to use an efficient contraceptive (e.g. birth control pill or an intra-uterine device for 3 months previous to start of the trial medication or diaphragm plus a spermicide).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Aalborg Hospital South

Aalborg, 9100, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev County Hospital

Herlev, 2730, Denmark

Location

Herlev Hospital Hematological Department

Herlev, 2730, Denmark

Location

Herning District Hospital

Herning, 7400, Denmark

Location

Hilleroed Hospital

Hilleroed, 3400, Denmark

Location

Odense University Hospital

Odense, 5000 C, Denmark

Location

Roskilde County Hospital

Roskilde, 4000, Denmark

Location

Viborg Hospital

Viborg, 8800, Denmark

Location

Related Publications (1)

  • Mouridsen HT, Langer SW, Buter J, Eidtmann H, Rosti G, de Wit M, Knoblauch P, Rasmussen A, Dahlstrom K, Jensen PB, Giaccone G. Treatment of anthracycline extravasation with Savene (dexrazoxane): results from two prospective clinical multicentre studies. Ann Oncol. 2007 Mar;18(3):546-50. doi: 10.1093/annonc/mdl413. Epub 2006 Dec 21.

    PMID: 17185744RESULT

MeSH Terms

Interventions

Dexrazoxane

Intervention Hierarchy (Ancestors)

RazoxaneDiketopiperazinesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Henning T Mouridsen, MD, Dr. med.

    Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 24, 2007

Study Start

June 1, 2001

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

October 21, 2015

Record last verified: 2013-11

Locations

DK(9)