Ignite Creation Date:
2024-05-05 @ 9:44 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00957086
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2009-08-11
Brief Title:
Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head Neck Cancer
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Centre Singapore
Study Overview
Official Title:
Phase III Double-Blind Placebo-Controlled Study of Post-Operative Adjuvant Concurrent Chemo-Radiotherapy With or Without Nimotuzumab for Stage IIIIV Head Neck Squamous Cell Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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 aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma HNSCC The investigators hypothesize that the addition of nimotuzumab a recombinant humanized murine immune antibody that blocks both epidermal growth factor EGF and transforming growth factor TGF to the current gold standard of concurrent chemoradiotherapy CCRT 78 an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage
Detailed Description:
The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma HNSCC We hypothesize that the addition of nimotuzumab a recombinant humanized murine immune antibody that blocks both epidermal growth factor EGF and transforming growth factor TGF to the current gold standard of concurrent chemoradiotherapy CCRT 78 an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage We have designed a phase III randomized study that includes a placebo arm We assume a 10 increase in 2 year disease free survival from 60 to 70 To achieve statistical significance at 90 power we calculate the need for 355 patients per arm assuming also a 10 dropout rate We aim to accomplish this study with the involvement of a multidisciplinary team of surgical radiation and medical oncologists actively involved in the management of HNSCC coming from multiple institutions and spanning at least 12 different countries For quality assurance we will have the involvement of Singapore Clinical Research Institute who will lead the data coordination and ensure fidelity of data collected and statistical analysis the European Society of Therapeutic Radiation Oncology EQUAL-ESTRO for radiation dose and fields and an international independent panel of medical oncologist radiation oncologist and biostatistician for the Data Monitoring Committee DMC This committee will monitor significant events and advise on continuation or termination of trial Concurrent with the randomized trial we will be collecting bio specimens including blood tumour and saliva pre-treatment and on completion of surgical resections We hypothesize that there are important biomarkers including clusters of genes cancer stem cells that will predict prognosis and treatment response The analyses performed will be very powerful because of the large sample size the specimens are collected prospectively and because the statistical analyses will be multivariate incorporating not only treatment but biological and staging data
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