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New trial tests chemo combo to stop rare adrenal Cancer's return

NCT ID NCT03583710

Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether adding chemotherapy (cisplatin and etoposide) to the standard drug mitotane after surgery works better than mitotane alone for patients with adrenocortical carcinoma at high risk of recurrence. The study plans to enroll 240 adults with stage I-III disease who had their tumor removed. The main goal is to see which approach delays or prevents the cancer from coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mitotane, cisplatin, etoposide
What this could lead to
If successful, this could show that adding chemotherapy to mitotane after surgery reduces the chance of adrenocortical carcinoma coming back in high-risk patients.
What could go wrong
This is an early-stage Phase 3 trial with only 240 participants, so results may not apply to all patients. Chemotherapy adds significant side effects, and it's unclear if the combination is better than mitotane alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have a histologically confirmed diagnosis of ACC (Weiss score of \>= 3). (LinWeiss-Bisceglia system will be used for oncocytic ACC). * Have a high risk of relapse defined as: Stage I-III ACC (according to the European Network for the Study of Adrenal Tumors \[ENSAT\] classification) within 90 days of surgical resection of primary tumor with curative intent with either microscopically complete resection (R0, defined as no evidence of microscopic residual disease according to surgical reports, histopathology, and perioperative imaging), microscopically positive margins (R1), or undetermined margins (RX, based on surgical or pathological reports without unequivocal evidence of metastasis in the perioperative imaging). Each participating center will determine the pathological stages and resection margins AND Ki67 \> 10% (to be determined by an experienced pathologist in each participating center and preferably via quantitative imaging analysis). * Have perioperative imaging (computed tomography \[CT\] with contrast, magnetic resonance imaging \[MRI\] of the chest/abdomen/pelvis, or fluorodeoxyglucose positron emission tomography \[FDG-PET\] CT) without unequivocal evidence of disease within 8 weeks before randomization. Patients with indeterminate non-specific nodules (\< 1 cm for soft tissue lesions and \< 1.5 cm in the short dimension for lymph nodes) will be permitted to participate in this study. * Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Be able to comply with the protocol procedures. * Provide written informed consent. Exclusion Criteria: * The 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 disease. * They have a history of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years. * They have renal insufficiency (estimated glomerular filtration rate \[GFR\] \< 50 mL/min/1.73 m\^2). * They have significant liver insufficiency (serum bilirubin \> 2 times the upper normal range) * They have significant liver insufficiency (serum alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 times the upper normal range) * Impaired bone marrow reserve (neutrophils \< 1000/mm\^3) * Impaired bone marrow reserve (platelets \< 100,000/mm\^3) * Pregnancy or breast feeding. * They have known congestive heart failure (ejection fraction \< 45%). The extent of cardiac testing will depend on the judgment of the local principal investigator (PI). In general, in patients with a history of cardiac disease, it is recommended to obtain a baseline two-dimensional echocardiogram as standard of care to document ejection fraction. In patients without prior cardiac disease, a baseline electrocardiogram (EKG) is sufficient if there is no evidence of acute ischemic changes or prior evidence of myocardial infarction. If EKG results are abnormal (ischemic changes, significant arrhythmia, or suggestion of prior myocardial infarction), a two-dimensional echocardiogram will be obtained to assess ejection fraction. Cardiac imaging and EKG may not be needed in patients assigned to mitotane who do not have prior cardiac history and have low suspicion for cardiac symptoms to reflect standards of clinical practice. Similarly, utilizing cardiac imaging and EKG within the past 12 months is permitted if there is no suspicion for cardiac issues. * They have preexisting grade 2 peripheral neuropathy. * They underwent previous or current treatment with mitotane or other antineoplastic drugs for ACC. * They underwent previous radiotherapy for ACC. * They have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would, in the judgment of the investigator, pose excess risk associated with study participation or administration of the involved drugs or that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

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Conditions

The condition(s) this trial relates to.

adrenal cortex carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ensat stage I adrenal cortex carcinoma Ensat stage II adrenal cortex carcinoma Ensat stage III adrenal cortex carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Akademiska Sjukhuset

    RECRUITING

    Uppsala, Sweden

  • CHU Angers, Hôpital Larrey

    RECRUITING

    Angers, 49933, France

  • CHU Besançon, Hôpital Jean Minjoz

    RECRUITING

    Besançon, 25000, France

  • CHU Bordeaux - Hôpital Haut Lévèque

    RECRUITING

    Pessac, 33600, France

  • CHU Brest, Hôpital La Cavale Blanche

    ACTIVE_NOT_RECRUITING

    Brest, 29200, France

  • CHU Nantes, Hôpital René et Guillaume Laënnec

    ACTIVE_NOT_RECRUITING

    Nantes, 44093, France

  • CHU Nantes, Hôpital René et Guillaume Laënnec

    RECRUITING

    Nantes, 44093, France

  • CHU Poitiers

    RECRUITING

    Poitiers, 86000, France

  • CHU Reims

    RECRUITING

    Reims, 51092, France

  • CHU Toulouse, Hôpital Larrey

    RECRUITING

    Toulouse, 31059, France

  • CHU Toulouse, Hôpital Rangueil

    ACTIVE_NOT_RECRUITING

    Toulouse, 31400, France

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, 25000, France

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • HCL Hôpital Louis Pradel

    NOT_YET_RECRUITING

    Lyon, 69877, France

  • HUS, Hôpital Hautepierre

    NOT_YET_RECRUITING

    Strasbourg, 67000, France

  • Hôpital COCHIN

    ACTIVE_NOT_RECRUITING

    Paris, 75014, France

  • Hôpital Cochin

    RECRUITING

    Paris, 75014, France

  • Hôpital Cochin, AP-HP

    RECRUITING

    Paris, 75014, France

  • Hôpital Cochin, AP-HP

    ACTIVE_NOT_RECRUITING

    Paris, 75014, France

  • Institut de Cancérologie de l'Ouest (ICO)

    ACTIVE_NOT_RECRUITING

    Angers, 49055, France

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Sweden

  • LMU Klinikum München

    RECRUITING

    Munich, 80336, Germany

  • Lyon HCL

    RECRUITING

    Lyon, 69002, France

  • M D Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Maria Sklodowska-Curie National Research Institute of Oncology

    ACTIVE_NOT_RECRUITING

    Gliwice, 44-102, Poland

  • Marseille Hôpital Nord

    RECRUITING

    Marseille, 13015, France

  • Marseille Hôpital de la Conception

    RECRUITING

    Marseille, France

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Sweden

  • Siteman Cancer Center at Washington University

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

  • Skånes Universitetssjukhus

    RECRUITING

    Lund, Sweden

  • Strasbourg HUS Hautepierre

    ACTIVE_NOT_RECRUITING

    Strasbourg, 67000, France

  • University of Michigan Comprehensive Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Universitätsklinikum Würzburg

    RECRUITING

    Würzburg, 97080, Germany