Public trial registry of the CCC-Munich

Trial ADIUVO

Trial Trial design Status In-/Exclusion Therapy Participants Documents Permissions Tumorboards

Trial
World
Trial acronym
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ADIUVO
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Full title
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Wirksamkeit einer adjuvanten Mitotane-Behandlung zur Verlängerung des
Rezidiv-freien Überlebens bei Patienten mit Nebennierenkarzinom mit
niedrigem bis mittleren Rezidiv-Risiko

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Description
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The ADIUVO study is a prospective, randomized, open-label, controlled, international, phase III trial for patients with ACC after radical resection.

In a parallel group design, patients will be randomized 1:1 to receive adjuvant therapy with mitotane or observational follow-up only. The overall study duration is 4 years from initial recruitment. Key inclusion criteria are: histologically confirmed diagnosis of ACC according to Weiss system; patient age ≥18 years; low/intermediate risk of recurrence defined as ENS@T stage I-III ACC, no evidence of microscopically residual disease and Ki-67 (MIB1) labeling index ≤ 10%. Key exclusion criteria are: history of prior malignancy; previous or current treatment with mitotane or other antineoplastic drugs; time between primary surgery and randomization >3 months, and repeated surgery for ACC recurrence. In the treatment arm, mitotane will be administered orally and adjusted according to target plasma levels (> 14 μg/l) and tolerability. Mitotane will be administered until ACC recurrence, intolerable toxicity, and consent withdrawal or until a treatment period of 2 years has been reached.

In the control arm, patients will receive no adjuvant treatment but will be monitored closely for recurrence with the same procedures as for treated patients.

Visit the website for more information: https://www.epiclin.it/adiuvo

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EudraCT number
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World
NCT number
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World
Responsible organization
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KUM - Med4 - Medizinische Klinik und Poliklinik IV Lmu
Indications
Classification Code Description
ICD-10-GM C74.- Bösartige Neubildung der Nebenniere
Trial design
World
Trial type
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Interventional
World
Blinding type
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Double blinded
Status
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Status
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Recruitment active
Votes
World
Institutional review board - vote
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Positive
World
PEI - vote
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Positive
Initiiation & lock
World
Date of lock (planned / actual)
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Unknown / Unknown
Participants
Function Prename Surname Organization
World Responsible contact Felix Beuschlein KUM - Med4 - Medizinische Klinik und Poliklinik IV Magnifier
World Principal Investigator Felix Beuschlein KUM - Med4 - Medizinische Klinik und Poliklinik IV Magnifier