localized Adrenocortical CarcInomA with high risk of recurrence MedDRA version: 20.0 Level: PT Classification code 10001388 Term: Adrenocortical carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: CISPLATINO ACCORD HEALTHCARE ITALIA - 1MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 10 ML
Product Name: CISPLATINO
Product Code: [CISPLATINO]
Pharmaceutical For
Sponsors
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed diagnosis of ACC (Weiss score of = 3); all tumor specimens can be reviewed a posteriori by a reference pathologis - High risk of relapse within 60 days of surgical resection of primary tumor with curative intent with either microscopically complete resection (R0, microscopically positive margins (R1), or undetermined margins (RX, based on surgical or pathological reports without unequivocal evidence of metastasis in the perioperative imaging). - Ki67=10% (to be determined by an experienced pathologist in each participating center and preferably via quantitative imaging analysis). - Have perioperative imaging (CT with contrast or MRI of the chest/abdomen/pelvis) demonstrating no unequivocal evidence of disease within 4 weeks before randomization. Patients with indeterminate non-specific nodules (=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - The time between primary surgery and randomization is >60 days - They have undergone repeated surgery for recurrence of disease - They have a history of recent or active prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, breast ductal carcinoma in situ, or other treated malignancies where there has been no evidence of disease for at least 2 years - They have renal insufficiency (estimated glomerular filtration rate [GFR] 2 times the upper normal range and/or serum alanine aminotransferase [ALT] or aspartate aminotransferase [AST]>3 times the upper normal range). GFRs will be calculated according to the validated formula (MDRD) - They are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of adjuvant chemotherapy with cisplatin plus etoposide at the above mentioned doses with or without mitotane (according to center preferences) (arm A) versus no treatment or adjuvant mitotane (according to center preference) (arm B) in terms 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. Radiologists will be blinded to treatment group. Raised levels of adrenocortical hormones as the only sign of disease progression will not be considered as true progression ;Secondary Objective: -To assess overall survival (OS), defined as the time interval between the date of randomization and the date of death from any cause. -To assess toxicity and adverse events, graded according to the NCI-CTCAE (version 4.03). -To assess the effect of disease stage, microscopically positive margins (R1) and Ki67 expression on clinical outcomes. -To assess the predictive role of Ki67 expression for chemotherapy efficacy -To assess the predictive role of histopathologic characteristics (Weiss-score) for chemotherapy efficacy ;Primary end point(s): The primary end point of will be the assessment of therapy efficacy through the evaluation of progression free survival (PFS). Analysis will be performed every 16 weeks (overall 2 years treatment) by imaging the chest/abdomen/pelvis by either computed tomography (CT; with slice thickness of 5 mm or less) or magnetic resonance imaging (MRI). ;Timepoint(s) of evaluation of this end point: every 16 weeks (overall 2 years treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): serius event adverse;Timepoint(s) of evaluation of this end point: every time in the study | — |
Countries
Italy
Contacts
Public ContactPROGETTAZIONE RICERCA CLINICA E STU
ASST SPEDALI CIVILI DI BRESCIA
Outcome results
None listed