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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cisplatin — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Mitotane — DRUG
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Aug 20, 2018

Status verified

Apr 2026

Primary completion

Jan 1, 2029

Completion

Jan 1, 2029

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (mitotane)
  Patients receive mitotane PO daily on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (mitotane, etoposide, cisplatin)
  Patients receive mitotane as in Arm A. Patients also receive cisplatin IV over 2 hours on day 1 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recurrence-free survival (RFS) [ Time Frame: From the time of randomization up to 2 years ]

Central Contacts

• Jeena Varghese
  713-792-2841
  [email protected]

Locations (3)

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