Adrenocortical CarcinomaPhase 3ADIUVONCT00777244
Efficacy of Adjuvant Mitotane Treatment (ADIUVO)
A Phase 3 study testing MITOTANE in people with Adrenocortical Carcinoma, run by University of Turin, Italy at 28 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenocortical Carcinoma
- What is being tested?
- MITOTANE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 28 sitesin 7 countries
- Study dates
- Apr 2008to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of ACC according to Weiss system by a national reference pathologist who has to be nominated before study initiation.
- 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
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- 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
Who cannot join
- Time between primary surgery and randomization > 3 months.
- 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
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- 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.
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
Italy11 sites, 8 recruiting
- Recruiting
UO Oncologia Medica - AO Spedali Civili
Brescia, 25123
Alfredo Berruti, alfredo.berruti@gmail.com
Anna Scalvini, annascalvini@gmail.com
- Recruiting
A.O.Universitaria Arcispedale S.Anna Ferrara
Ferrara, Fe, 44100
Prof. Ettore Degli Uberti
Ettore Degli Uberti
- Not yet recruiting
Università degli studi di Firenze
Florence
Massimo Mannelli
Massimo Mannelli
- Active, not recruiting
Azienda Ospedaliera di Foggia
Foggia
- Recruiting
Ospedale Cà Granda-Niguarda-Milano
Milan
Paola Loli
Paola Loli
- Recruiting
Azienda Ospedaliera San Luigi
Orbassano, 10043
Paola Perotti, +390119026 ext. 017, oncotrial.sanluigi@gmail.com
- Recruiting
Department of Clinical and Biological Sciences, University of Turin, Internal Medicine 1
Orbassano, 10043
Paola Perotti, +390119026 ext. 513, oncotrial.sanluigi@gmail.com
Massimo Terzolo, MD
- Active, not recruiting
Azienda Ospedaliera Padova
Padova
- Not yet recruiting
Università degli studi di Palermo
Palermo
Vittorio Gebbia
- Active, not recruiting
Policlinico Universitario A. Gemelli
Roma
- Recruiting
A.O.U. San Giovanni Battista - Molinette
Torino
Enzo Gigo, MD
Enzo Ghigo
France6 sites, 6 recruiting
- Recruiting
Endocrinologie - CHU Besançon Hôpital Jean Minjoz
Besançon, 25000
Alfred Perforinis, alfred.penfornis@univ-fcomte.fr
Annie Clergeot, aclergeot@chu-besancon.fr
- Recruiting
Endocrinologie - CHU Lyon Hôpital Pierre Wertheimer
Bron, 69677
Michel Pugeat, michel.pugeat@chu-lyon.fr
Cecilie Nozieres, cecile.nozieres@chu-lyon.fr
- Recruiting
Endocrinologie - Hôpital A. Michallon
La Tronche, 38700
Olivier Cabre, 33 04 76 76 ext. 5175, OlivierChabre@chu-grenoble.fr
Olivier Cabre
- Recruiting
Endocrinologie - Cochin, APHP
Paris, 75679
Bertagna Xavier, +330158 ext. 411790, xavier.bertagna@cch.aphp.fr
Rossella Libè, +330158 ext. 413249, Emrossella.libe@cch.aphp.fr
- Recruiting
Endocrinologie - CHU Toulouse Hôpital Larrey
Toulouse
Philippe Caron, caron.p@chu-toulouse.fr
Delphine Vezzosi, vezzosi.d@chu-toulouse.fr
- Recruiting
Endocrinologie - Institut de Cancérologie Gustave Roussy
Villejuif, 94805
Eric Baudin, +330142 ext. 114242, eric.baudin@igr.fr
Cécile CHOUGNET, +330142 ext. 115224, Cecile.chougnet@igr.fr
Germany6 sites, 6 recruiting
- Recruiting
University Hospital Campus Mitte Charitè, Berlin
Berlin, 10117
Marcus PD Quinkler, 030-450 ext. 514259, marcus.quinkler@charite.de
Marcus Quinkler, MD
- Recruiting
University Hospital of Dresden
Dresden, 01307
Stefan Bornstein, MD, 0351-458 ext. 5955, stefan.bornstein@uniklinikum-dresden.de
Stefan Bornstein, MD
- Not yet recruiting
University Hospital of Düsseldorf
Düsseldorf, 40001
Holger Willenberg, MD, Holger.Willenberg@uni-duesseldorf.de
Holger Willenberg
- Recruiting
Center for Endocrine Tumors - ENDOC
Hamburg, 20357
Stephan Petersenn, MD, 040-401 ext. 87985, stephan.petersenn@endoc-med.de
Stephan Petersenn
- Recruiting
University Medicin Centre of Munchen
München, 80336
Felix Beuschlein, MD, 089 -5160 ext. 2110, felix.beuschlein@med.uni-muenchen.de
Martin Fassnacht, Fassnacht_m@medizin.uni-wuerzburg.de
- Recruiting
University Hospital Wuerzburg, Endocrinology
Würzburg, 97080
Martin MD Fassnacht, 0931-201- ext. 39021, Fassnacht_M@medizin.uni-wuerzburg.de
Patricia Sculler, Schuller_P@medizin.uni-wuerzburg.de
United States2 sites, 1 recruiting
- Active, not recruiting
Endocrine Oncology - University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0921
- Recruiting
Medical Oncology Branch - Center for Cancer Research - National Cancer Institute
Bethesda, Maryland, 20892-1903
Tito Fojo, fojot@mail.nih.gov
Maureen Edgerly, 301-435 ext. 5604, edgerlym@mail.nih.gov
Canada1 site, 1 recruiting
- Recruiting
Endocrinologie - Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, 3840
André Lacroix, andre.lacroix@umontreal.ca
André Lacroix
Netherlands1 site, 1 recruiting
- Recruiting
Dept. of Internal Medicine Maxima Medisch Centrum
Eindhoven, 5600 PD
Harm Haak, MD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Cancer Research UK Clinical Trials Unit (CRCTU) - School of Cancer Sciences - University of Birmingham
Birmingham, Edgbaston, 152TT
Wiebke Arlt, w.arlt@bham.ac.uk
Ana Huges, a.i.hughes@bham.ac.uk
About this study
Official title: Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence
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
Read the detailed 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.
- Conditions
- Adrenocortical Carcinoma
- Being tested
- MITOTANE
- Keywords
- mitotane, adjuvant therapy, disease free survival
- Medical subject headings
- Adrenocortical Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MITOTANEDrug
Also called Mitotane (Lysodren)
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.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up | No intervention | Arm B |
| Mitotane | Experimental | Arm A Receives: Drug: MITOTANE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free survival
Survival in years
Measured: Till the last follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adrenocortical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Berruti, University of Turin, Italy
- Investigators
- Massimo Terzolo, MD, Study chair, Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, ItalyMartin Fassnacht, MD, Study director, Department of Internal Medicine, University of Wuerzburg, GermanyAlfredo Berruti, MD, Study chair, Medical Oncology, Department of Clinical and Biological Sciences, University of TurinEric Baudin, MD, Principal investigator, Oncologie Endocrinienne et Médecine Nucléaire, Institut Gustave Roussy, Villejuif, France.Harm Haak, MD, Principal investigator, Department of Internal Medicine, Máxima Medical Centre, Eindhoven, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777244
- Sponsor's protocol ID
- EudraCT 2007-007262-38
- Acronym
- ADIUVO
- Status last verified
- May 2017
- First submitted
- 21 Oct 2008
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 17554118Terzolo 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.
PubMed 37619579
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence
- ClinicalTrials.gov ID
- NCT00777244
- Acronym / sponsor ID
- ADIUVO / EudraCT 2007-007262-38
- Conditions
- Adrenocortical Carcinoma
- Keywords
- mitotane, adjuvant therapy, disease free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up | No intervention | –Arm B |
| Mitotane | Experimental | Drug: MITOTANEArm A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed diagnosis of ACC according to Weiss system by a national reference pathologist who has to be nominated before study initiation.
- Low-intermediate risk of relapse defined as:
- 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)
Key exclusion criteria (9 listed)
- Time between primary surgery and randomization > 3 months.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MITOTANEAlso: Mitotane (Lysodren)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. | Drug | Mitotane |
Primary outcome
Disease Free survival
Time frame: Till the last follow up
Survival in years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Background: PubMed 17554118Terzolo 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.
- Derived from this study: PubMed 37619579Terzolo 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.
- study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Terzolo, MD study chair
Internal Medicine, Department of Clinical and Biological Sciences, University of Turin, Italy
Martin Fassnacht, MD study director
Department of Internal Medicine, University of Wuerzburg, Germany
Alfredo Berruti, MD study chair
Medical Oncology, Department of Clinical and Biological Sciences, University of Turin
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MITOTANE in people with Adrenocortical Carcinoma, run by University of Turin, Italy at 28 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy, France, Germany, United States, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Perotti (+390119026 ext. 643, oncotrial.sanluigi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free survival (time frame: Till the last follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00777244, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.