Adjuvant mitotane vs. mitotane with cisplatin/etoposide after primary surgical resection of localised adrenocortical carcinoma with high risk of recurrence (ADIUVO-2 Trial): A pragmatic, randomised, low-intervention phase III, clinical trial with an observational arm.

Adrenocortical carcinoma

RFS will be defined as the time between the date of randomisation until documentation of radiological evidence of local recurrence, radiological evidence of distant recurrence or date of death from any cause, whichever occurs first. Patients will be censored at the date of their last evaluation in which they were known to be alive and recurrence-free, regardless of whether recurrence status was verified during that contact (e.g., phone contact).

Overall survival is defined as the time interval between the date of randomisation and the date of death from any cause., Assessment of the effect of serum mitotane levels, disease stage, Ki67 index and status of resection margins on clinical outcomes based on physical examination, complete blood count with differential, serum chemistry profile, endocrine assessment and serum mitotane measurement at baseline and until ACC recurrence. The effect will also be assessed using cross-sectional imaging (CT with contrast medium, MRI) of the chest/abdomen/pelvis or FDG PET-CT every 12 weeks until ACC recurrence., The effect of early vs. late start of adjuvant therapy on clinical outcomes will be assessed in a similar manner as above., Quality of life will be measured at baseline, 6 weeks and 6 months after the initiation of adjuvant therapy, and at the end of study participation (recurrence or completing study treatments) using a validated quality of life questionnaire (EORTC QLQ-C30)., Serious adverse events, grade 3 and above, will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0) until one year after end of treatment.

No related papers found yet.

France, Germany, Sweden