Actively Recruiting
Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)
Led by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Updated on 2024-08-01
80
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of ACC
- Locally advanced or metastatic disease not suitable for radical surgery
- ECOG performance status 0 to 2
- Use of effective contraception
- Life expectancy longer than 3 months
- Age over 18 years
- Adequate bone marrow reserve with neutrophils >1,000/mm3 and/or platelets >80,000/mm3
- Adequate renal, liver, and cardiac function
- Ability to comply with protocol procedures and provide written informed consent
You will not qualify if you...
- Recent or active prior malignancy except certain cured cancers with no disease for at least 2 years
- Renal insufficiency with GFR less than 50 mL/min/1.73 m2
- Significant liver insufficiency with bilirubin more than twice normal or ALT/AST more than three times normal
- Pregnancy or breastfeeding
- Congestive heart failure with ejection fraction less than 45%
- Preexisting grade 2 peripheral neuropathy
- Previous or current treatment with mitotane or other anticancer drugs for ACC
- Prior radiotherapy for ACC
- Any severe medical or psychiatric condition or lab abnormality that increases risk or makes the patient unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Alfredo Berruti
Brescia, Italy, 25123
Actively Recruiting
Research Team
A
Aldo Roccaro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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