Clinical TrialID 8206
Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)
NCT05913427
Adrenocortical Carcinoma
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8206
- Evidence Id
- 8206
- Core Evidence Id
- 8206
- Source Clinical Trial Id
- 8204
- Herb2 Clinical Trial Id
- HBCT008204
- Nct Id
- NCT05913427
- Title
- Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)
- Status
- Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Adrenocortical Carcinoma
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Etoposide, doxorubicin, cisplatin and Mitotane plus Megestrol Acetate 160 MG|DRUG: Etoposide, doxorubicin, cisplatin and Mitotane plus Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 80
- Outcome Measure
- Evaluation of the activity of the combination regimen (EDP-M plus progesterone (EDP-MP) versus EDP-M plus placebo) in advanced/ metastatic patients with ACC., Comparison of proportion of patients attaining an Objective Response (Objective Response Rate, ORR), evaluated by RECIST criteria between the 2 treatment arms., 18 months
- Sponsor Collaborator
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Funded By
- OTHER
- Location
- Alfredo Berruti, Brescia, 25123, Italy
- Other Id
- ASSTBS-FARONCO- PESETA-20
- Start Date
- 2022-06-08
- Primary Completion Date
- 2027-06-08
- Completion Date
- 2027-06-08
- First Posted
- 2023-06-22
- Results First Posted
- Last Update Posted
- 2024-08-01
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05913427
- Title Cn
- Title En
- Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)
- Bilingual Status
- semi_complete