Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2008-04-30
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk Melanoma
NCT04309409
Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
NCT03551626
Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence
NCT06692556
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
NCT04099251
A Study to Assess APO866 for the Treatment of Advanced Melanoma
NCT00432107
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Follow-up
Arm B
No interventions assigned to this group
Mitotane
Arm A
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Low-intermediate risk of relapse defined as:
* Stage I-III (according to ENSAT classification 2008; see Appendix 2)
* Microscopically complete resection, defined as no evidence of microscopic residual disease based on surgical reports, histopathology and post-operative imaging. Detailed pathological and surgical reports prepared according to guidelines detailed in appendix x and y should be available for assessment.
* Ki 67 \< 10%
* Post-operative imaging (thoracic and whole abdominal CT with contrast medium or MRI) demonstrating no evidence of disease within 4 weeks from randomization
* Age \> 18 years
* ECOG performance status 0-2 (Appendix 3)
* Adequate bone marrow reserve (neutrophils \> 1000/mm3 and platelets \> 80000/ mm3)
* Ability to comply with the protocol procedures (including geographic accessibility)
* Written informed consent
Exclusion Criteria
* Repeat surgery for recurrence of disease
* Presence of autonomous adrenocortical hormone secretion despite the absence of disease detectable with imaging techniques
* History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years
* Renal insufficiency (creatinine clearance \< 40 ml/min) or liver insufficiency (serum bilirubin \> 2 times the upper normal range and/or serum transaminases (AST/SGOT, ALT/SGPT, but not gamma Glutamyl Transpeptidase) \>3 times the upper normal range). Creatinine clearance may be calculated according to validated formulas (Crockoft's or MDRD)
* Pregnancy or breast feeding
* Previous or current treatment with mitotane or other antineoplastic drugs for ACC
* Previous radiotherapy of the tumor bed (for ACC).
* Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Turin, Italy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alfredo Berruti
Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Massimo Terzolo, MD
Role: STUDY_CHAIR
Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy
Martin Fassnacht, MD
Role: STUDY_DIRECTOR
Department of Internal Medicine, University of Wuerzburg, Germany
Alfredo Berruti, MD
Role: STUDY_CHAIR
Medical Oncology, Department of Clinical and Biological Sciences, University of Turin
Eric Baudin, MD
Role: PRINCIPAL_INVESTIGATOR
Oncologie Endocrinienne et Médecine Nucléaire, Institut Gustave Roussy, Villejuif, France.
Harm Haak, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Máxima Medical Centre, Eindhoven, The Netherlands
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Oncology Branch - Center for Cancer Research - National Cancer Institute
Bethesda, Maryland, United States
Endocrine Oncology - University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Endocrinologie - Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, , Canada
Endocrinologie - CHU Besançon Hôpital Jean Minjoz
Besançon, , France
Endocrinologie - CHU Lyon Hôpital Pierre Wertheimer
Bron, , France
Endocrinologie - Hôpital A. Michallon
La Tronche, , France
Endocrinologie - Cochin, APHP
Paris, , France
Endocrinologie - CHU Toulouse Hôpital Larrey
Toulouse, , France
Endocrinologie - Institut de Cancérologie Gustave Roussy
Villejuif, , France
University Hospital Campus Mitte Charitè, Berlin
Berlin, , Germany
University Hospital of Dresden
Dresden, , Germany
University Hospital of Düsseldorf
Düsseldorf, , Germany
Center for Endocrine Tumors - ENDOC
Hamburg, , Germany
University Medicin Centre of Munchen
München, , Germany
University Hospital Wuerzburg, Endocrinology
Würzburg, , Germany
A.O.Universitaria Arcispedale S.Anna Ferrara
Ferrara, Fe, Italy
UO Oncologia Medica - AO Spedali Civili
Brescia, , Italy
Università degli studi di Firenze
Florence, , Italy
Azienda Ospedaliera di Foggia
Foggia, , Italy
Ospedale Cà Granda-Niguarda-Milano
Milan, , Italy
Azienda Ospedaliera San Luigi
Orbassano, , Italy
Department of Clinical and Biological Sciences, University of Turin, Internal Medicine 1
Orbassano, , Italy
Azienda Ospedaliera Padova
Padua, , Italy
Università degli studi di Palermo
Palermo, , Italy
Policlinico Universitario A. Gemelli
Roma, , Italy
A.O.U. San Giovanni Battista - Molinette
Torino, , Italy
Dept. of Internal Medicine Maxima Medisch Centrum
Eindhoven, , Netherlands
Cancer Research UK Clinical Trials Unit (CRCTU) - School of Cancer Sciences - University of Birmingham
Birmingham, Edgbaston, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Prof. Ettore Degli Uberti
Role: primary
Massimo Mannelli
Role: primary
Paola Loli
Role: primary
Vittorio Gebbia
Role: primary
Enzo Gigo, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Terzolo M, Angeli A, Fassnacht M, Daffara F, Tauchmanova L, Conton PA, Rossetto R, Buci L, Sperone P, Grossrubatscher E, Reimondo G, Bollito E, Papotti M, Saeger W, Hahner S, Koschker AC, Arvat E, Ambrosi B, Loli P, Lombardi G, Mannelli M, Bruzzi P, Mantero F, Allolio B, Dogliotti L, Berruti A. Adjuvant mitotane treatment for adrenocortical carcinoma. N Engl J Med. 2007 Jun 7;356(23):2372-80. doi: 10.1056/NEJMoa063360.
Terzolo M, Fassnacht M, Perotti P, Libe R, Kastelan D, Lacroix A, Arlt W, Haak HR, Loli P, Decoudier B, Lasolle H, Quinkler M, Haissaguerre M, Chabre O, Caron P, Stigliano A, Giordano R, Zatelli MC, Bancos I, Fragoso MCBV, Canu L, Luconi M, Puglisi S, Basile V, Reimondo G, Kroiss M, Megerle F, Hahner S, Kimpel O, Dusek T, Nolting S, Bourdeau I, Chortis V, Ettaieb MH, Cosentini D, Grisanti S, Baudin E, Berchialla P, Bovis F, Sormani MP, Bruzzi P, Beuschlein F, Bertherat J, Berruti A. Adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma (ADIUVO): an international, multicentre, open-label, randomised, phase 3 trial and observational study. Lancet Diabetes Endocrinol. 2023 Oct;11(10):720-730. doi: 10.1016/S2213-8587(23)00193-6. Epub 2023 Aug 21.
Related Links
Access external resources that provide additional context or updates about the study.
study website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT 2007-007262-38
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.