OncoMatch/Clinical Trials/NCT05913427

Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)

Is NCT05913427 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Etoposide, doxorubicin, cisplatin and Mitotane plus Megestrol Acetate 160 MG for adrenocortical carcinoma.

Phase 2RecruitingAzienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaNCT05913427Data as of May 2026

Treatment: Etoposide, doxorubicin, cisplatin and Mitotane plus Megestrol Acetate 160 MG — This is a prospective randomized, double blind, placebo controlled phase II study planned in patients with advanced ACC. The study will be conducted at ASST Spedali Civili Hospital and University of Brescia in Brescia.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: antineoplastic drugs (mitotane)

Previous or current treatment with mitotane or other antineoplastic drugs for ACC

Cannot have received: radiation therapy

Previous radiotherapy for ACC

Lab requirements

Blood counts

adequate bone marrow reserve (neutrophils >1,000/mm3 and/or platelets >80,000/mm3)

Kidney function

renal insufficiency (estimated glomerular filtration rate [GFR]<50 mL/min/1.73 m2)

Liver function

significant liver insufficiency (serum bilirubin>2 times the upper normal range and/or serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST]>3 times the upper normal range)

Cardiac function

congestive heart failure (ejection fraction<45%)

Adequate bone marrow reserve (neutrophils >1,000/mm3 and/or platelets >80,000/mm3) and organ function (including renal, liver and cardiac function); Renal insufficiency (estimated glomerular filtration rate [GFR]<50 mL/min/1.73 m2) or significant liver insufficiency (serum bilirubin>2 times the upper normal range and/or serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST]>3 times the upper normal range); Congestive heart failure (ejection fraction<45%)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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