Efficacy of Adjuvant Mitotane Treatment (ADIUVO) (ADIUVO)
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|ClinicalTrials.gov Identifier: NCT00777244|
Recruitment Status : Recruiting
First Posted : October 22, 2008
Last Update Posted : May 8, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Adrenocortical Carcinoma||Drug: MITOTANE||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
No Intervention: Follow-up
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.
Other Name: Mitotane (Lysodren)
- Disease Free survival [ Time Frame: Till the last follow up ]Survival in years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777244
|Contact: Paola Perotti||+390119026 ext firstname.lastname@example.org|
|Contact: Paola Sperone||+390119026 ext email@example.com|
|Study Chair:||Massimo Terzolo, MD||Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy|
|Study Director:||Martin Fassnacht, MD||Department of Internal Medicine, University of Wuerzburg, Germany|
|Study Chair:||Alfredo Berruti, MD||Medical Oncology, Department of Clinical and Biological Sciences, University of Turin|
|Principal Investigator:||Eric Baudin, MD||Oncologie Endocrinienne et Médecine Nucléaire, Institut Gustave Roussy, Villejuif, France.|
|Principal Investigator:||Harm Haak, MD||Department of Internal Medicine, Máxima Medical Centre, Eindhoven, The Netherlands|