Trial · NCT05913427
Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)
NCT05913427, Phase 2, Recruiting, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC). Trials, record NCT05913427. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05913427
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy of Addition of Progesterone to Standard Chemotherapy in Adrenocortical Carcinoma (ACC)
- NCT number
- NCT05913427
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Conditions
- Adrenocortical Carcinoma
- Interventions
- Etoposide, doxorubicin, cisplatin and Mitotane plus Megestrol Acetate 160 MG, Etoposide, doxorubicin, cisplatin and Mitotane plus Placebo
- First posted
- 2023-06-22
- Last updated
- 2024-08-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 18 months | Comparison of proportion of patients attaining an Objective Response (Objective Response Rate, ORR), evaluated by RECIST criteria between the 2 treatment arms. |
| Secondary | Evaluation of the impact of the combination of the two treatments on hormone response in patients with secreting ACC; | 18 months | Changes in serum cortisol from baseline in the two treatment arms; |
| Secondary | Evaluation of the impact of the combination of the two treatments on hormone response in patients with secreting ACC; | 18 months | Changes in serum UFC from baseline in the two treatment arms; |
| Secondary | Evaluation of the impact of the combination of the two treatments on hormone response in patients with secreting ACC; | 18 months | Changes in serum salivary cortisol from baseline in the two treatment arms; |
| Secondary | Evaluation of the impact of the combination of the two treatments on hormone response in patients with secreting ACC; | 18 months | Changes in ACTH from baseline in the two treatment arms; |
| Secondary | Evaluation of the impact of the combination of the two treatments on hormone response in patients with secreting ACC; | 18 months | Changes in serum 11-deoxycortisol from baseline in the two treatment arms; |
| Secondary | Evaluation of the impact of the combination of the two treatments on hormone response in patients with secreting ACC; | 18 months | Changes in serum aldosterone from baseline in the two treatment arms; |
| Secondary | Evaluation of the impact of the combination of the two treatments on hormone response in patients with secreting ACC; | 18 months | Changes in serum PRA from baseline in the two treatment arms; |
| Secondary | Evaluation of the impact of the combination of the two treatments on hormone response in patients with secreting ACC; | 18 months | Changes in serum androstenedione from baseline in the two treatment arms; |
| Secondary | Evaluation of the impact of the combination of the two treatments on hormone response in patients with secreting ACC; | 18 months | Changes in serum DHEA-S from baseline in the two treatment arms; |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05913427
GET https://conductscience.org/api/trials/v1/NCT05913427/registered