Last updated on February 2018

Efficacy of Adjuvant Mitotane Treatment (ADIUVO)


Brief description of study

Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a retrospective multicenter international study showing that postoperative mitotane treatment was associated with a significant reduction of the risk of relapse and death. However, these promising results need confirmation in a randomized prospective study. Caution should be adopted particularly in patients with low risk of disease relapse, in whom the benefit of therapy should be weighted against the side effects. Even if an adjuvant treatment seems justified in patients at high risk of relapse, a randomised prospective study is needed to assess whether such a treatment is efficacious in patients at low-intermediate risk.

The purpose of the present study is to determine whether adjuvant mitotane treatment is effective in prolonging the disease free survival in patients with adrenocortical carcinoma at low-intermediate risk of progression who underwent radical resection

Detailed Study Description

Endpoints Primary : To compare DFS (Disease Free Survival), defined as the time between the date of randomization until documentation of any of the following failures (whichever occurs first): -local or distant recurrence of disease;-death from any cause or completion of follow-up.

Secondary

To compare OS (Overall Survival), defined as the time interval between the date of randomization and the date of death from any cause or the last known alive date; To compare quality of life measured by EORTC-QLQ-C30 To compare toxicity, graded according to the NCI-CTG criteria; To compare DFS and OS in patients who achieve or not serum mitotane concentrations > 14 mg/L; To compare DFS and OS between the 2 arms in patients subgroups stratified according to: type of hormone secretion, stage of disease, histopathologic characteristics.

Clinical Study Identifier: NCT00777244

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Tito Fojo

Medical Oncology Branch - Center for Cancer Research - National Cancer Institute
Bethesda, MD United States
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Paola Perotti

Endocrine Oncology - University of Michigan Comprehensive Cancer Center
Ann Arbor, MI United States
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André Lacroix

Endocrinologie - Centre hospitalier de l'Universit de Montr al (CHUM)
Montreal, Canada
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Alfred Penfornis

Endocrinologie - CHU Besan on H pital Jean Minjoz
Besancon, France
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Michel Pugeat

Endocrinologie - CHU Lyon H pital Pierre Wertheimer
Bron, France
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Olivier Cabre

Endocrinologie - H pital A. Michallon
La Tronche, France
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Xavier Bertagna

Endocrinologie - Cochin, APHP
Paris, France
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Philippe Caron

Endocrinologie - CHU Toulouse H pital Larrey
Toulouse, France
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Eric Baudin

Endocrinologie - Institut de Canc rologie Gustave Roussy
Villejuif, France
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Marcus Quinkler, MD

University Hospital Campus Mitte Charit , Berlin
Berlin, Germany
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Stefan Bornstein, MD

University Hospital of Dresden
Dresden, Germany
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Stephan Petersenn

Center for Endocrine Tumors - ENDOC
Hamburg, Germany
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Martin Fassnacht, MD

University Hospital Wuerzburg, Endocrinology
Wurzburg, Germany
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Ettore Degli Uberti

A.O.Universitaria Arcispedale S.Anna Ferrara
Ferrara, Italy
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Alfredo Berruti

UO Oncologia Medica - AO Spedali Civili
Brescia, Italy
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Massimo Mannelli

Universit degli studi di Firenze
Firenze, Italy
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Paola Perotti

Azienda Ospedaliera di Foggia
Foggia, Italy
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Paola Loli

Ospedale C Granda-Niguarda-Milano
Milano, Italy
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Paola Perotti

Azienda Ospedaliera San Luigi
Orbassano, Italy
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Massimo Terzolo, MD

Department of Clinical and Biological Sciences, University of Turin, Internal Medicine 1
Orbassano, Italy
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Paola Perotti

Azienda Ospedaliera Padova
Padova, Italy
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Vittorio Gebbia

Universit degli studi di Palermo
Palermo, Italy
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Paola Perotti

Policlinico Universitario A. Gemelli
Roma, Italy
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Enzo Ghigo

A.O.U. San Giovanni Battista - Molinette
Torino, Italy
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Harm Haak, MD

Dept. of Internal Medicine Maxima Medisch Centrum
Eindhoven, Netherlands
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Wiebke Arlt

Cancer Research UK Clinical Trials Unit (CRCTU) - School of Cancer Sciences - University of Birmingham
Birmingham, United Kingdom
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Holger Willenberg

University Hospital of D sseldorf
Düsseldorf, Germany
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Felix Beuschlein

University Medicin Centre of Munchen
München, Germany
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Recruitment Status: Open


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