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Tests treatment safety and results for Adrenocortical Carcinoma
Official title Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)
ClinicalTrials.gov ID: NCT05913427
What this study is testing
What is Etoposide, doxorubicin, cisplatin and Mitotane plus Megestrol Acetate 160 MG?
Etoposide, doxorubicin, cisplatin and Mitotane plus Megestrol Acetate 160 MG is an investigational medicine, being studied as a potential treatment for adrenocortical carcinoma.
Also referred to as Megace.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- History of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in...
- Renal insufficiency (estimated glomerular filtration rate [GFR]\ 2 times the upper normal range and/or serum alanine aminotransferase [ALT] or...
- 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
See the full eligibility 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.
- 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...
- Renal insufficiency (estimated glomerular filtration rate [GFR]\ 2 times the upper normal range and/or serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST]\>3 times the upper normal range). GFRs will...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brescia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.