Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176254
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2005-09-09
Brief Title:
Paclitaxel Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer
Sponsor:
Susanne Arnold
Organization:
University of Kentucky
Study Overview
Official Title:
Paclitaxel Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2023-04
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 utilizes two cycles of Paclitaxel and Carboplatin chemotherapies followed by four small doses of radiation prior to other treatment surgery or radiation This study is evaluating if radiation as a chemoenhancer increases the response rate of initial therapy
Detailed Description:
Cancers of the head and neck HN 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 complete response 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 Improved disease-free survival has been demonstrated with a variety of agents 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 hyperfractionated radiation and alternating chemotherapy and radiation
One exciting new chemotherapeutic agent Paclitaxel has been shown to radiosensitize cancer cell lines in vitro Recent studies have added Carboplatin to Paclitaxel in tandem or concurrently with radiation in hopes of improving response rates From in-vitro data it appears that the optimum schedule for the combination of Paclitaxel and radiation is to first induce G2M arrest with Paclitaxel and follow this with radiation therapy In a recent study by Chendil et al a novel radiation scheme appeared to enhance the response of both p53 wild type and p53 mutant cancer cell lines to chemotherapy In vitro data with Carboplatin also indicates an additive effect when given prior to irradiation using various cell lines What has not been evaluated is whether a neoadjuvant regimen of Paclitaxel and Carboplatin followed by 4 small fractions of radiation can be given safely and effect an improved response rate in patients with bulky T2 Stage III and IV HN cancer We propose the use of two cycles of Paclitaxel and Carboplatin followed by four small fractions of radiation prior to definitive treatment surgery or radiation It is hoped that using radiation as a chemoenhancer will increase the response rate to induction therapy in this population of patients
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 Improved disease-free survival has been demonstrated with a variety of agents 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 hyperfractionated radiation and alternating chemotherapy and radiation
One exciting new chemotherapeutic agent Paclitaxel has been shown to radiosensitize cancer cell lines in vitro Recent studies have added Carboplatin to Paclitaxel in tandem or concurrently with radiation in hopes of improving response rates From in-vitro data it appears that the optimum schedule for the combination of Paclitaxel and radiation is to first induce G2M arrest with Paclitaxel and follow this with radiation therapy In a recent study by Chendil et al a novel radiation scheme appeared to enhance the response of both p53 wild type and p53 mutant cancer cell lines to chemotherapy In vitro data with Carboplatin also indicates an additive effect when given prior to irradiation using various cell lines What has not been evaluated is whether a neoadjuvant regimen of Paclitaxel and Carboplatin followed by 4 small fractions of radiation can be given safely and effect an improved response rate in patients with bulky T2 Stage III and IV HN cancer We propose the use of two cycles of Paclitaxel and Carboplatin followed by four small fractions of radiation prior to definitive treatment surgery or radiation It is hoped that using radiation as a chemoenhancer will increase the response rate to 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