Adrenocortical carcinoma · 2024-520160-34-00
PROSPECTIVE, PHASE II STUDY TO EVALUATE THE EFFICACY OF ADDITION OF PROGESTERONE TO STANDARD CHEMOTHERAPY ACCORDING TO EDP SCHEME PLUS MITOTANE IN PATIENTS WITH ADVANCED ADRENAL CORTICAL CARCINOMA - PESETA TRIAL
- Status
- Authorised (EU CTIS)Approved to run; CTIS does not say whether it is recruiting — ask the site
- Phase
- Phase 2
- Sponsor
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Registry records
- CTIS 2024-520160-34-00 (Authorised)Registry last updated 2026-10-22
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · condition · confidence 0.95 | Histologically confirmed diagnosis of ACC | "Histologically confirmed diagnosis of ACC" | |
| inclusion inclusion · stage extent · confidence 0.95 | Locally advanced or metastatic disease not amenable to radical surgery resection | "Locally advanced or metastatic disease not amenable to radical surgery resection" | |
| inclusion inclusion · performance status · confidence 0.97 | ECOG performance status 0-2 | "ECOG performance status 0-2" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Effective contraception | "Effective contraception" | |
| inclusion inclusion · life expectancy · confidence 0.85 | Life expectancy > 3 months | "Life expectancy > 3 months" | |
| inclusion inclusion · age sex · confidence 0.98 | Age >= 18 years | "Age >= 18 years" | |
| inclusion inclusion · lab value · confidence 0.80 | Adequate bone marrow reserve (neutrophils >1,000/mm3 and/or platelets >80,000/mm3) | "neutrophils >1,000/mm3" | |
| inclusion inclusion · lab value · confidence 0.80 | Adequate bone marrow reserve (neutrophils >1,000/mm3 and/or platelets >80,000/mm3) | "platelets >80,000/mm3" | |
| inclusion inclusion · organ function · confidence 0.30 | Adequate organ function (including renal, liver and cardiac function) | "organ function (including renal, liver and cardiac function)" | |
| inclusion inclusion · consent · confidence 0.30 | Be able to comply with the protocol procedures and provide written informed consent. | "Be able to comply with the protocol procedures and provide written informed consent." | |
| exclusion exclusion · comorbidity · confidence 0.90 | 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 | "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" | |
| exclusion exclusion · organ function · confidence 0.95 | Renal insufficiency (estimated glomerular filtration rate [GFR]<50 mL/min/1.73 m2) | "estimated glomerular filtration rate [GFR]<50 mL/min/1.73 m2" | |
| exclusion exclusion · organ function · confidence 0.95 | Significant liver insufficiency (serum bilirubin>2 times the upper normal range | "serum bilirubin>2 times the upper normal range" | |
| exclusion exclusion · organ function · confidence 0.95 | Significant liver insufficiency (serum ALT or AST>3 times the upper normal range) | "serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST]>3 times the upper normal range" | |
| exclusion exclusion · pregnancy contraception · confidence 0.30 | Pregnancy or breast feeding | "Pregnancy or breast feeding" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Congestive heart failure (ejection fraction<45%) | "Congestive heart failure (ejection fraction<45%)" | |
| exclusion exclusion · comorbidity · confidence 0.93 | Preexisting grade 2 peripheral neuropathy | "Preexisting grade 2 peripheral neuropathy" | |
| exclusion exclusion · prior therapy · confidence 0.95 | Previous or current treatment with mitotane or other antineoplastic drugs for ACC | "Previous or current treatment with mitotane or other antineoplastic drugs for ACC" | |
| exclusion exclusion · prior therapy · confidence 0.95 | Previous radiotherapy for ACC | "Previous radiotherapy for ACC" | |
| exclusion exclusion · comorbidity · confidence 0.30 | 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. | "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." |
Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.
Full eligibility text as the registry publishes it
Inclusion criteria: 1. Histologically confirmed diagnosis of ACC 2. Locally advanced or metastatic disease not amenable to radical surgery resection 3. ECOG performance status 0-2 4. Effective contraception 5. Life expectancy > 3 months 6. Age >= 18 years 7. Adequate bone marrow reserve (neutrophils >1,000/mm3 and/or platelets >80,000/mm3) and organ function (including renal, liver and cardiac function) 8. Be able to comply with the protocol procedures and provide written informed consent. Exclusion criteria: 1. 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 2. 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) 3. Pregnancy or breast feeding 4. Congestive heart failure (ejection fraction<45%) 5. Preexisting grade 2 peripheral neuropathy 6. Previous or current treatment with mitotane or other antineoplastic drugs for ACC 7. Previous radiotherapy for ACC 8. 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.
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Sites (0)
The registry lists no sites. Countries: Italy.