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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
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520160-34-00
Enrollment
80
Registered
2025-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenocortical carcinoma

Brief summary

Comparison of proportion of patients attaining an Objective Response (Objective Response Rate, ORR), evaluated by RECIST criteria [29] between the 2 treatment arms.

Interventions

DRUGMEGACE 160 mg compresse
DRUGDOXORUBICIN
DRUGCISPLATIN
DRUGETOPOSIDE
DRUGThe placebo prepared for the study consists in oval shaped biconvexed tablets that are scored on one side an engraved with "160" on the other side.
DRUGMITOTANE

Sponsors

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Comparison of proportion of patients attaining an Objective Response (Objective Response Rate, ORR), evaluated by RECIST criteria [29] between the 2 treatment arms.—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026