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Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence

StatusRecruiting
PhasePhase 3
Started2018-08-20
View on ClinicalTrials.gov ↗

Amendment history

2026-07-15
Study Status v23
Re-verified, no change to tracked fields
2026-04-06
Study Status, Contacts/Locations v22
Trial sites expanded: 25 → 33 locations
2026-01-28
Study Status, Contacts/Locations v21
Study sitescontacts updated at 1 of 25 sites
2025-10-23
Study Status, Sponsor/Collaborators, Contacts/Locations v20
Study sites23→25
Collaborators5 to 1 entries
Assistance Publique - Hôpitaux de Paris Wuerzburg University Hospital University Hospital Munich Skanes Universitetssjukhus
2025-09-29
Study Status, Contacts/Locations v19
Study sites8→23
Show 18 earlier versions
2025-07-29
Study Status v18
Re-verified, no change to tracked fields
2025-06-01
Study Status, Sponsor/Collaborators v17
Primary completion date2025-01-22→2029-01-01
Completion date2025-01-22→2029-01-01
Collaborators2 to 5 entries
Wuerzburg University Hospital University Hospital Munich Skanes Universitetssjukhus
2024-10-11
Study Status v16
Re-verified, no change to tracked fields
2024-09-30
Study Status, Contacts/Locations v15
Study sites5→8
2024-04-09
Study Status v14
Re-verified, no change to tracked fields
2023-12-15
Study Status, Sponsor/Collaborators, Contacts/Locations v13
Study sites4→5
Collaborators1 to 2 entries
Assistance Publique - Hôpitaux de Paris
2023-09-22
2 amendments v11-v12
2 re-verifications since 2022-12-13, no change to tracked fields
2022-06-06
Study Status, Contacts/Locations v10
Study sites4 entries, revised
The Maria Sklodowska-Curie C.M.C.C.I.ONational KrakowResearch Institute of Oncology
2022-05-13
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 4 sites
2021-04-22
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v8
Study sites1→4
InterventionsCisplatin (Drug), Etoposide (Drug), Mitotane (Drug), Quality-of-Life Assessment (Procedure)→Cisplatin (Drug), Etoposide (Drug), Mitotane (Drug), Quality-of-Life Assessment (Other)
Eligibility criteria+476 characters
[...] FDG-PET] CT) without unequivocal evidence of disease within 48 weeks before randomization. Patients with indeterminate non [...] e time between primary surgery and randomization > 90 days. Gross residual disease after surgery (R2 resection) High suspicion for metastatic disease on perioperative imaging They have undergone repeated surgery for recurrence of disea [...] ted glomerular filtration rate [GFR] < 50 mL/min/1.73 m^2). GFRs will be calculated according to the validated formula (Modification of Diet in Renal Disease [MDRD]). They have significant liver insufficiency (serum bilirubin > [...] e known congesti [...]
Study description-150 characters
PRIMARY OBJECTIVESOBJECTIVE: I. To compare the effect of adjuvant mitotane treatment al [...] . Assess the effect of early start (1-6 weeks from surgery) versus (vs.) late start (> 6 weeks from surgery) of adjuvant therapy on clinical outcomes. IV. Assess serious adverse events (grade 3 and above) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.03). V. Measure quality of life at baseline, 6 weeks, 6 months [...] mor cells, and micro ribonucleic acid [microRNA]). OUTLINE: ParticipantsPatients are randomized to 1 of 2 arms. ARM A: ParticipantsPa [...] [...]
Collaborators2 to 1 entries
AmercianNational AustralianCancer Asian Adrenal AllianceInstitute (A5NCI) European Network for the Study of Adrenal Tumors
Study title-15 characters
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating ParticipantsPatients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence (ADIUVO-2)
2021-03-24
4 amendments v4-v7
4 re-verifications since 2019-09-13, no change to tracked fields
2018-08-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-09-22→confirmed 2018-08-20
Study sitesdetails revised at 1 of 1 site
2018-08-15
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v2
Primary completion date2019-03-22→2025-01-22
Completion date2019-03-22→2025-01-22
Collaborators1 to 2 entries
NationalAmercian CancerAustralian InstituteAsian Adrenal Alliance (NCIA5) European Network for the Study of Adrenal Tumors
Study title+11 characters
[...] age I-III Adrenocortical Cancer With High Risk of Recurrence (ADIUVO-2)
2018-07-11
Study Status, Arms and Interventions, Contacts/Locations v1
Study sitescontacts updated at 1 of 1 site
2018-06-28
Original filing
This phase III trial studies how well mitotane alone works compared to mitotane with cisplatin and etoposide when given after surgery in treating patients with adrenocortical cancer that has a high risk of coming back (recurrence). Cortisol can cause the growth of adrenocortical tumor cells. Antihormone therapy, such as mitotane, may lessen the amount of cortisol made by the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether mitotane alone or mitotane with cisplatin and etoposide after surgery works better in treating patients with adrenocortical carcinoma.
Trial Details
NCT Number NCT03583710
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions ENSAT Stage I Adrenal Cortex Carcinoma, ENSAT Stage II Adrenal Cortex Carcinoma, ENSAT Stage III Adrenal Cortex Carcinoma
Enrollment 240 participants
Start Date 2018-08-20
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-16