Adding progesterone to standard chemotherapy for advanced adrenocortical carcinoma
Prospective, Phase II Study to Evaluate the Efficacy of Addition of Progesterone to Standard Chemotherapy According to Etoposide-Doxorubicin-Cisplatin Scheme Plus Mitotane (EDP-M) in Patients With Advanced Adrenocortical Carcinoma (ACC)
PHASE2 · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · NCT05913427
This study is testing if adding a form of progesterone to standard chemotherapy can help people with advanced adrenocortical carcinoma feel better and improve their treatment results.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Brescia) |
| Trial ID | NCT05913427 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the efficacy of adding megestrol acetate, a form of progesterone, to the standard chemotherapy regimen of etoposide, doxorubicin, cisplatin, and Mitotane in patients with advanced adrenocortical carcinoma (ACC). The study is designed as a prospective randomized, double-blind, placebo-controlled trial, aiming to determine if the addition of progesterone can enhance the cytotoxic effects of the chemotherapy in ACC cells. Participants will be monitored for improvements in treatment efficacy and overall outcomes compared to those receiving a placebo.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed advanced ACC that is not amenable to radical surgery.
Not a fit: Patients with recent or active prior malignancies or significant organ insufficiencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced adrenocortical carcinoma who currently have limited options.
How similar studies have performed: While the addition of hormonal therapies to chemotherapy has been explored in other cancers, this specific combination in ACC is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed diagnosis of ACC * Locally advanced or metastatic disease not amenable to radical surgery resection * ECOG performance status 0-2 * Effective contraception * Life expectancy \> 3 months * Age \> 18 years * Adequate bone marrow reserve (neutrophils \>1,000/mm3 and/or platelets \>80,000/mm3) and organ function (including renal, liver and cardiac function) * Be able to comply with the protocol procedures and provide written informed consent. Exclusion Criteria: * 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 * 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). GFRs will be calculated according to the validated formula (MDRD) * Pregnancy or breast feeding * Congestive heart failure (ejection fraction\<45%) * Preexisting grade 2 peripheral neuropathy * Previous or current treatment with mitotane or other antineoplastic drugs for ACC * Previous radiotherapy for ACC * Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration or that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Where this trial is running
Brescia
- Alfredo Berruti — Brescia, Italy (RECRUITING)
Study contacts
- Principal investigator: Alfredo Berruti — Asst Degli Spedali Civili Di Brescia
- Study coordinator: Aldo Roccaro
- Email: coordinamento.ricerca@asst-spedalicivili.it
- Phone: +390303996851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adrenocortical Carcinoma