Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094497
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2004-10-19
Brief Title:
Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment FIRM-ACT
Sponsor:
Collaborative Group for Adrenocortical Carcinoma Treatment
Organization:
Collaborative Group for Adrenocortical Carcinoma Treatment
Study Overview
Official Title:
First International Randomized Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether treatment with etoposide doxorubicin cisplatin and mitotane EDPM prolongs survival as compared to streptozotocin and mitotane SzM in patients with advanced adrenocortical carcinoma ACC whose disease is not amenable to complete surgical resection
Detailed Description:
The Firm-ACT trial is the first ever conducted randomized controlled phase III trial in adrenocortical carcinoma ACC a rare malignancy with poor prognosis It will provide results leading to the establishment of an urgently needed gold standard chemotherapy regimen for patients with locally advanced or metastatic ACC To this end the trial compares the two most promising drug combinations investigated in phase II trials considered by the International Consensus Conference on Adrenal Cancer Ann ArborUSA 2003 as valuable first line treatments for advanced ACC The first regimen consists of etoposide doxorubicin cisplatin plus mitotane EDP-M the second regiment employs streptozotocin plus mitotane Sz-M Over a period of five years this international trial will include 300 patients with advanced ACC from different European countries Blood mitotane concentrations will be monitored aiming at drug levels between 14 - 20 mgL Patients not responding to the first line treatment will be switched to the alternative regimen The primary objective of this trial is to investigate whether EDP-M given as first line treatment will prolong survival as compared to Sz-M Secondary endpoints are quality of life time to progression best overall response rate and duration of response In addition the trial evaluates the role of reaching therapeutic mitotane serum concentrations for survival and tumour response and assesses the value of the two alternative treatment regimens as second line therapy in advanced ACC Moreover the FIRM-ACT trial will generate a lasting structural basis for successful future trials in ACC
In a substudy of 40 patients a detailed analysis of the pharmacokinetics of oral mitotane will be analysed Two different mitotane treatment regimens low dose vs high dose will be compared
In a substudy of 40 patients a detailed analysis of the pharmacokinetics of oral mitotane will be analysed Two different mitotane treatment regimens low dose vs high dose will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None