Phenoxybenzamine Versus Doxazosin in PCC Patients
Information source: University Medical Centre Groningen
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pheochromocytoma
Intervention: Phenoxybenzamine (Drug); Doxazosin (Drug)
Phase: Phase 4
Sponsored by: University Medical Centre Groningen
Official(s) and/or principal investigator(s):
Michiel N. Kerstens, MD PhD, Study Director, Affiliation: University Medical Centre Groningen
Thera P. Links, MD PhD, Principal Investigator, Affiliation: University Medical Centre Groningen
Gütz J. Wietasch, MD PhD, Principal Investigator, Affiliation: University Medical Centre Groningen
Jaques W. Lenders, MD PhD, Principal Investigator, Affiliation: UMC St Radboud Nijmegen
G D. Valk, MD PhD, Principal Investigator, Affiliation: UMC Utrecht
E M. Eekhoff, MD PhD, Principal Investigator, Affiliation: Free University UMC Amsterdam
P H. Bisschop, MD PhD, Principal Investigator, Affiliation: Academical Medical Center Amsterdam
R A Feelders, MD PhD, Principal Investigator, Affiliation: Erasmus Medical Center Rotterdam
Bas Havekes, MD PhD, Principal Investigator, Affiliation: Maastricht University Medical Center
Peter Oomen, MD PhD, Principal Investigator, Affiliation: Medical Center Leeuwarden
I Eland, MD PhD, Principal Investigator, Affiliation: St. Antonius Ziekenhuis Nieuwegein
P H. Geelhoed- Duijvestijn, MD PhD, Principal Investigator, Affiliation: Medisch Centrum Haaglanden
P Groote Veldman, MD PhD, Principal Investigator, Affiliation: Medisch Spectrum Twente
H R Haak, MD PhD, Principal Investigator, Affiliation: Máxima Medisch Centrum
J R. Meinardi, MD PhD, Principal Investigator, Affiliation: Canisius-Wilhelmina Hospital
C B. Brouwer, MD PhD, Principal Investigator, Affiliation: Canisius-Wilhelmina Hospital
P L. van Battum, MD, Principal Investigator, Affiliation: Atrium Medical Center
A A. Franken, MD PhD, Principal Investigator, Affiliation: Isala Klinieken Zwolle
Michiel N Kerstens, MD PhD, Phone: 0031- 50-3613962, Email: email@example.com
- Rationale: The optimal preoperative medical management for patients with a
pheochromocytoma is currently unknown. In particular, there is no agreement with
respect to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor
antagonist to be administered before surgical resection of a pheochromocytoma. We
hypothesized that the competitive alfa1-antagonist doxazosin is superior to the
non-competitive alfa1- and alfa2-antagonist phenoxybenzamine.
- Objective: comparing effects of preoperative treatment with either phenoxybenzamine or
doxazosin on intraoperative hemodynamic control in patients undergoing surgical
resection of a pheochromocytoma.
- Study design: Randomised controlled open-label trial.
- Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign
- Intervention: Patients are randomised to receive oral treatment with either
phenoxybenzamine or doxazosin preoperatively.
- Main study parameters/endpoints: The main study parameter is defined as the frequency
of intraoperative blood pressure episodes outside the predefined target range after
pretreatment with either phenoxybenzamine or doxazosin.
In this multicenter trial, we compare the effects of two commonly used drugs in patients
being medically prepared for resection of a benign pheochromocytoma. Participants are not
subjected to an experimental treatment of any kind, as we merely aim to describe in detail
the perioperative course in general and, in particular, the intraoperative hemodynamic
control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A
routine diagnostic work-up for pheochromocytoma will be performed in all participants. One
extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and
participants need to record their symptoms in a diary. In addition, patients who are
pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with
an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least
2 - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment
with an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by
the nursing staff. The final site visit is planned at 30 days after surgery, in line with
Official title: Pheochromocytoma Randomised Study Comparing Adrenoreceptor Inhibiting Agents for Preoperative Treatment
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The number of patients demonstrating more than three intraoperative episodes of 5 minutes with blood pressure outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin.
To attain preoperative blood pressure target values without co-medication
Resolution of (paroxysmal) symptoms and signs of pheochromocytoma.
Need for additional antihypertensive agents
Adverse effects of study medication
Length of preoperative treatment in either outpatient or inpatient clinic.
Control of blood pressure and heart rate.
Length of hospital stay.
Composite semi-quantitative score of intra- and postoperative hemodynamic control.
Perioperative cardiovascular morbidity.
Composite endpoint of perioperative mortality and perioperative cardiovascular morbidity.
Minimum age: 18 Years.
Maximum age: N/A.
- age > 18 years
- diagnosis of benign Pheochromocytoma (adrenal or extra-adrenal, sporadic or
- elevated plasma and/or urinary (nor)metanephrines. From each patient, a blood
sample is collected for measurement of plasma (nor)metanephrines with the
reference laboratory assay (i. e. XLC-MS/MS) at the Department of Laboratory
Medicine of the UMCG.
- localisation of PCC by anatomical (MRI/CT) and functional imaging (I123-MIBG
scintigraphy or 18F-DOPA PET)
- planned for surgical removal of the PCC
- age < 18 years
- malignant PCC, i. e. presence of lesions on imaging studies suggestive of distant
- severe hemodynamic instability before surgery necessitating admission to intensive
- incapability to adhere to the study protocol
Locations and Contacts
Michiel N Kerstens, MD PhD, Phone: 0031- 50-3613962, Email: firstname.lastname@example.org
Department of Endocrinology, University Medical Center Groningen, Groningen 9700 RB, Netherlands; Recruiting
Michiel N. Kerstens, MD PhD, Phone: 0031-50-3613962, Email: email@example.com
Thera P. Links, MD PhD, Principal Investigator
Gütz J. Wietasch, MD PhD, Principal Investigator
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Starting date: December 2011
Last updated: January 25, 2012