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Efficacy of Adjuvant Mitotane Treatment (ADIUVO)

NCT00777244 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-05-08

No results posted yet for this study

Summary

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

Conditions

  • Adrenocortical Carcinoma

Interventions

DRUG

MITOTANE

mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance on day 2 to 3 g/day, on day 3 to 4.5 g/day, and on day 4 to 6 g/day. A dose of 6 g/day will be administered until first mitotane blood level is assessed. Further adjustment of dosage will be performed according to blood concentrations and tolerability.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Massimo Terzolo, MD · Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy

  • Martin Fassnacht, MD · Department of Internal Medicine, University of Wuerzburg, Germany

  • Alfredo Berruti, MD · Medical Oncology, Department of Clinical and Biological Sciences, University of Turin

  • Eric Baudin, MD · Oncologie Endocrinienne et Médecine Nucléaire, Institut Gustave Roussy, Villejuif, France.

  • Harm Haak, MD · Department of Internal Medicine, Máxima Medical Centre, Eindhoven, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2018-12-31
Completion
2020-12-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00777244 on ClinicalTrials.gov