Ignite Creation Date:
2024-05-06 @ 2:45 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02128906
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2014-04-29
Brief Title:
Radiotherapy With Cisplatin vs Docetaxel-cetuximab in HNSCC ERCC1 Biomarker Enrichment and Interaction Design
Sponsor:
Christopher Wilke
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Randomized Phase II Study of Definitive Radiotherapy With Concurrent Cisplatin vs Docetaxel-cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma an ERCC1 Biomarker Enrichment and Interaction Design
Status:
RECRUITING
Status Verified Date:
2024-03
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 goal of this clinical research study is to learn which chemotherapy combination may be more effective in treating locally advanced head and neck squamous cell carcinoma HNSCC The side effects of these combinations will also be studied
This study treatment consists of intensity-modulated radiation therapy IMRT and concurrent chemotherapy For study chemotherapy patients will be randomized between cisplatin or the combination of docetaxel and cetuximab Subjects will be stratified depending on HPV status and the presence of ERCC-1 4F9 in the tumor prior to randomization The study will evaluate cisplatin vs docetaxel-cetuximab in the overall population and test which radiation and chemotherapy combination works best in relationship to how much ERCC-1 4F9 is expressed in a tumor
This study treatment consists of intensity-modulated radiation therapy IMRT and concurrent chemotherapy For study chemotherapy patients will be randomized between cisplatin or the combination of docetaxel and cetuximab Subjects will be stratified depending on HPV status and the presence of ERCC-1 4F9 in the tumor prior to randomization The study will evaluate cisplatin vs docetaxel-cetuximab in the overall population and test which radiation and chemotherapy combination works best in relationship to how much ERCC-1 4F9 is expressed in a tumor
Detailed Description:
If randomized to the cisplatin arm patients receive cisplatin 40 mgm2 administered intravenously IV once a week - 2 days for 7 weeks Per investigator discretion if radiation continues beyond 7 weeks due to technical factors not toxicity delays an 8th dose of concurrent cisplatin may be added
Cisplatin can be given either before or after the radiation therapy fraction that is given on the same day If a dose of cisplatin is omitted when radiotherapy is ongoing it will not be made up or added to the end of treatment The omitted dose and the reason for the omission should be recorded in the sites source documentation If radiotherapy is held cisplatin should be held during the treatment break and resumed when radiation restarts
Patients randomized to Cetuximab arm receive cetuximab 250 mgm2 IV over 60 minutes on a weekly schedule - 2 days Cetuximab may be administered either before or after the radiation fraction that is given on the same day Docetaxel will be administered at least 30 minutes following cetuximab It is not permitted to make up missed doses of cetuximab or docetaxel If a radiation therapy treatment break occurs cetuximab should be held When radiation restarts cetuximab should resume
Cetuximab will be given once a week - 2 days for a total of 7 doses concurrent with radiation therapy and docetaxel
Cisplatin can be given either before or after the radiation therapy fraction that is given on the same day If a dose of cisplatin is omitted when radiotherapy is ongoing it will not be made up or added to the end of treatment The omitted dose and the reason for the omission should be recorded in the sites source documentation If radiotherapy is held cisplatin should be held during the treatment break and resumed when radiation restarts
Patients randomized to Cetuximab arm receive cetuximab 250 mgm2 IV over 60 minutes on a weekly schedule - 2 days Cetuximab may be administered either before or after the radiation fraction that is given on the same day Docetaxel will be administered at least 30 minutes following cetuximab It is not permitted to make up missed doses of cetuximab or docetaxel If a radiation therapy treatment break occurs cetuximab should be held When radiation restarts cetuximab should resume
Cetuximab will be given once a week - 2 days for a total of 7 doses concurrent with radiation therapy and docetaxel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None