Ignite Creation Date:
2024-05-06 @ 10:16 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03217097
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2017-07-12
Brief Title:
MGMT-NET O6-methylguanine-DNA Methyltransferase MGMT Status in Neuroendocrine Tumors Predictive Factor of Response to Alkylating Agents
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
MGMT-NET O6-methylguanine-DNA Methyltransferase MGMT Status in Neuroendocrine Tumors Predictive Factor of Response to Alkylating Agents
Status:
COMPLETED
Status Verified Date:
2022-11
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:
MGMT-NET
Brief Summary:
Neuroendocrine tumors NET are rare but their incidence is growing Alkylating agents ALKY are one of the main systemic treatments used at least for advanced duodeno-pancreatic NETs with a response rate of 30 to 40 and a median progression-free survival of 4 to 18 months Chemotherapy is one of the few therapeutic weapons along with everolimus somatostatin analogs and metabolic radiotherapy for lung NETs called typical and atypical carcinoids even if the level of proof of efficacy for these treatments is lower than for duodeno-pancreatic NETs Considering the available retrospective data O6-Methylguanine-DNA methyltransferase MGMT appears to be a predictive factor of the response to ALKY Oxaliplatin OX has demonstrated an interesting activity with response rates between 17 and 30 In a first retrospective study we showed that Gemox is effective in NET and more recently that its activity is similar to that of ALKYs but without being influenced by the MGMT status Prospective studies are needed but our data suggests that ALKY should be offered first to patients with methylated MGMT tumors while Oxaliplatin-based chemotherapy should be offered first to patients with unmethylated MGMT tumors
In this project we wish to evaluate the contribution of the MGMT methylation evaluated in the tumor in predicting the Objective Response OR in patients treated with ALKY and to evaluate a treatment with alkylating agents versus Oxaliplatin in patients with a duodeno-pancreatic or lung or unknown primitive NET
In this project we wish to evaluate the contribution of the MGMT methylation evaluated in the tumor in predicting the Objective Response OR in patients treated with ALKY and to evaluate a treatment with alkylating agents versus Oxaliplatin in patients with a duodeno-pancreatic or lung or unknown primitive NET
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None