Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05839886
Other study ID # CCEMD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date December 1, 2024

Study information

Verified date May 2023
Source Shanghai Jiao Tong University School of Medicine
Contact Luming Wu, PhD
Phone +86-021-64370045
Email wulum@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This work will evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024.


Description:

Background: Adrenocortical Carcinoma (ACC) is a rare malignancy of the adrenal cortex. The annual incidence of ACC is thought to be between 0.5-2.0 cases per million. Adjunctive therapy with mitotane may be offered post- surgically to minimise risk of recurrence. Aims: Evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024. Methods: Cortisol, ACTH, Gastrointestinal reactions and CNS Toxicity will be measured. SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Patients will be included, within ACC with mitotane. Data will be tested for normality, described as MeanĀ± SD, compared using paired sample t-test with 5% p-value for significance and 95% confidence interval (CI).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Age = 18 years old and = 75 years Diagnosis of Patients with adrenocortical cancer Gender: males and females Provide written informed consent Satisfactory compliance Exclusion Criteria: Patients with renal insufficiency (Cr>2 times the upper limit of normal). Patients with a history of liver cirrhosis. Patients who are currently using corticosteroids. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%). Patients with stroke and acute myocardial infarction in the past 6 months. Patients during pregnancy and lactation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary Documentation of adverse effects Adverse effects will be documented using the NCI CTC AE v5 from starting mitotane treatment until discontinuation of mitotane (since this is very variable from patient to patient no specific number of days or weeks can be entered (standard therapy would be about 2 years)
Secondary Tumor treatment response According to RECIST (version 1.1). 2 years
See also
  Status Clinical Trial Phase
Completed NCT04373265 - Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol) Phase 1
Recruiting NCT06050057 - Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy
Recruiting NCT06066333 - Study of Radiotherapy and Pembrolizumab in People With Adrenocortical Carcinoma Phase 2
Recruiting NCT03127774 - Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma Phase 2
Completed NCT01048892 - Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features Phase 1
Recruiting NCT00457587 - Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma
Recruiting NCT00669266 - Adrenal Tumors - Pathogenesis and Therapy
Recruiting NCT05999292 - Phase 1 Study of 68Ga-R8760 Phase 1
Completed NCT05361083 - First-in-human Evaluation of [18F]CETO Early Phase 1
Recruiting NCT05660889 - Adrenal Vein Sampling as a Tool to Identify Biomarkers That Aid the Diagnosis of Adrenocortical Carcinoma
Completed NCT00003038 - Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors Phase 1
Enrolling by invitation NCT03474237 - A Prospective Cohort Study for Patients With Adrenal Diseases
Recruiting NCT04119024 - Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors Phase 1
Enrolling by invitation NCT05036434 - Phase II Trial of Pembrolizumab Plus Lenvatinib in Advanced Adrenal Cortical Carcinoma Phase 2
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2
Not yet recruiting NCT06333314 - Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI Phase 2
Withdrawn NCT00469469 - Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma Phase 2
Completed NCT00002608 - Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors Phase 2
Recruiting NCT05634577 - A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma Phase 2
Completed NCT00454103 - Evaluation of 123I-Iodometomidate for Adrenal Scintigraphy Phase 1/Phase 2