Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176267
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2005-09-09
Brief Title:
Paclitaxel Carboplatin And Low Dose Radiation As Induction Therapy In Locally Advanced Head And Neck Cancer
Sponsor:
Susanne Arnold
Organization:
University of Kentucky
Study Overview
Official Title:
Paclitaxel Carboplatin And Low Dose Radiation As Induction Therapy In Locally Advanced Head And Neck Cancer
Status:
COMPLETED
Status Verified Date:
2023-05
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:
This study is being performed utilizing two cycles of Paclitaxel and Carboplatin plus low doses radiation as initial therapy prior to other treatment surgery or radiation The study is assessing if utilization of low doses radiation as a chemoenhancer will further increase the response rate seen with initial therapy
Detailed Description:
Squamous cell cancers of the head and neck SCCHN comprise 5 of all cancers with 40000 new cases diagnosed annually Surgery followed by irradiation or irradiation alone has been the standard of care for locally advanced Stage III and IV patients With this approach fewer than 30 of patients achieve long-term remission and most recur locoregionally Neoadjuvant chemotherapy has been administered prior to definitive therapy with response rates ranging from 60-90 with pathologic CR rates documented in 30-70 of clinical responders However large randomized trials have shown no improvement in overall survival Because induction chemotherapy alone does not appear to improve long-term disease free survival in advanced head and neck cancers concomitant chemotherapy and radiation has been pursued in patients with locally advanced head and neck cancers The concept of synergy between radiation and chemotherapy is well established in vitro Various schedules of radiation and chemotherapy have been utilized including weekly chemotherapy during radiation chemotherapy given every three weeks during radiation and alternating chemotherapy and radiation
One novel approach to capitalizes on the synergy between radiation and chemotherapy is the use of low doses fractionated radiation LDFRT as a chemotherapy enhancer In vitro data suggests that LDFRT enhances the response of both p53 wild type and p53 mutant cancer cell lines to chemotherapy Not only was the cell death fraction increased but there was no development of radioresistance in the cell lines studies when low doses of radiation were utilized This strategy was translated into a clinical trial using four 80-cGy fractions of radiation with Carboplatin and Paclitaxel Preliminary results have produced an impressive 85 response rate and this neoadjuvant regimen was safe and easy to deliver in patients with locally advanced SCCHN patients In recently published work by Belani a regimen using Carboplatin every four weeks combined with weekly Paclitaxel improved response rates in non-small cell lung cancer The delivery of chemotherapy on a weekly schedule would be of particular benefit when adding LDFRT because tumor cells could be exposed to LDFRT on multiple occasions per cycle of induction therapy without the theoretic development of radioresistance We propose to expand our understanding of LDFRT and chemotherapy by using two cycles of Paclitaxel and Carboplatin in a modification of the Belani regimen plus LDFRT as induction therapy prior to definitive treatment surgery or radiation It is hoped that using LDFRT as a chemoenhancer will further increase the response rate seen with induction therapy in this population of patients
One novel approach to capitalizes on the synergy between radiation and chemotherapy is the use of low doses fractionated radiation LDFRT as a chemotherapy enhancer In vitro data suggests that LDFRT enhances the response of both p53 wild type and p53 mutant cancer cell lines to chemotherapy Not only was the cell death fraction increased but there was no development of radioresistance in the cell lines studies when low doses of radiation were utilized This strategy was translated into a clinical trial using four 80-cGy fractions of radiation with Carboplatin and Paclitaxel Preliminary results have produced an impressive 85 response rate and this neoadjuvant regimen was safe and easy to deliver in patients with locally advanced SCCHN patients In recently published work by Belani a regimen using Carboplatin every four weeks combined with weekly Paclitaxel improved response rates in non-small cell lung cancer The delivery of chemotherapy on a weekly schedule would be of particular benefit when adding LDFRT because tumor cells could be exposed to LDFRT on multiple occasions per cycle of induction therapy without the theoretic development of radioresistance We propose to expand our understanding of LDFRT and chemotherapy by using two cycles of Paclitaxel and Carboplatin in a modification of the Belani regimen plus LDFRT as induction therapy prior to definitive treatment surgery or radiation It is hoped that using LDFRT as a chemoenhancer will further increase the response rate seen with induction therapy in this population of patients
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