Trial · NCT03723941
Adjuvant Chemotherapy vs. Observation/Mitotane After Primary Surgical Resection of Localized Adrenocortical CarcInoma
NCT03723941, Phase 3, Completed, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Adjuvant Chemotherapy vs. Observation/Mitotane After Primary Surgical Resection of Localized Adrenocortical CarcInoma. Trials, record NCT03723941. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03723941
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adjuvant Chemotherapy vs. Observation/Mitotane After Primary Surgical Resection of Localized Adrenocortical CarcInoma
- NCT number
- NCT03723941
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Conditions
- Adrenocortical Carcinoma
- Interventions
- Cisplatin plus Etoposide, Observation or Mitotane
- First posted
- 2018-10-30
- Last updated
- 2024-08-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of the recurrence-free survival (RFS) status in patientis treated with adiuvant chemotherapy with or without mitotane (arm A) versus no treatment or adjuvant mitotane (arm B). | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | Evaluation of recurrence-free survival (RFS). Recurrence will be objectively assessed every 16 weeks by imaging the chest/abdomen/pelvis by either computed tomography (CT; with slice thickness of 5 mm or less) or magnetic resonance imaging (MRI). Suspected lesions will be accurately measured in at least one dimension (the longest diameter in the plane of measurement will be recorded). Soft tissue lesions must have a minimum size of 10 mm, and suspected malignant lymph nodes must be more than 15 mm (short axis) to be considered pathological. |
| Secondary | Assessment of overal survival | From date of randomization until the date of death from any cause, assessed up to 36 months | defined as the time interval between the date of randomization and the date of death from any cause. |
| Secondary | Assessment of toxicity and adverse events | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | Toxicity and adverse events will be graded according to the NCI-CTCAE (version 4.03). |
| Secondary | Assessment of the predictive role of Ki67 expression for chemotherapy efficacy | Ki67 expression evaluated at the screening phase | Histological evaluation of KI67 expression on basal tumor tissue sections and correlation to chemotherapy efficacy |
| Secondary | Assessment of the predictive role of histopathologic characteristics (Weiss-score) for chemotherapy efficacy | Weiss score identified at the screening phase | Weiss score will be identified on basal tumor tissue resection based on the original Weiss criteria for malignancy (Am J Surg Pathol 1984;8:163), and will be correlated to chemotherapy efficacy. The Weiss scoring system is based on the recognition at light microscopy of nine morphological parameters: three of them are related to tumor structure, namely presence of eosinophilic ("dark") cytoplasm in more than 75% of tumor cells, of a "patternless" diffuse architecture, and of necrosis; three others are related to cytological features, namely presence of nuclear atypia, of mitotic index above 5 per 50 high-power fields, and of atypical mitoses; the remaining three are related to invasive tumor properties, including sinusoidal, venous, and capsular invasion. A diagnosis of malignancy is achieved if at least three parameters are identified out of 9 (scale from 0 to 9). |
| Other | BioBank | Baseline | Available tissue specimens (formalin-fixed paraffin-embedded or frozen tissues) plus one sample of serum, plasma and urine, will be collected before randomization for each patient enrolled in this study. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers17
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/NCT03723941
GET https://conductscience.org/api/trials/v1/NCT03723941/registered