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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

NCT03583710 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-07

No results posted yet for this study

Summary

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.

Conditions

  • ENSAT Stage I Adrenal Cortex Carcinoma
  • ENSAT Stage II Adrenal Cortex Carcinoma
  • ENSAT Stage III Adrenal Cortex Carcinoma

Interventions

DRUG

Cisplatin

Given IV

DRUG

Etoposide

Given IV

DRUG

Mitotane

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jeena Varghese · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2029-01-01
Completion
2029-01-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03583710 on ClinicalTrials.gov