Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05294900
Status:
UNKNOWN
Last Update Posted:
2022-03-25
First Post:
2022-03-15
Brief Title:
Trial of Neoadjuvant Therapy With Paclitaxel and Carboplatin in Operable Locally Advanced Head and Neck Cancer Patients
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Phase II Trial of Neoadjuvant Therapy With Paclitaxel and Carboplatin in Operable Locally Advanced Head and Neck Cancer Patients NEOS
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_RECRUITING
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:
NEOS
Brief Summary:
- Objective Primary objective To evaluate the major pathologic response mPR of locally advanced head and neck cancer after paclitaxel and carboplatin-induction chemotherapy followed by surgery
Secondary objective To evaluate the efficacy and safety of induction chemotherapy Outcome metrics Local relapse rate LRR Relapse-free survival RFS Overall survival OS Adverse reactions according to CTCAE 50 Exploratory Purpose To evaluate changes in circulating tumor cells CTC and immunodynamics before and after paclitaxel and carboplatin-induction chemotherapy through blood biopsy specimens and surgical specimen analysis
background
Chemoradiation CRT or chemotherapy Induction Chemotherapy IC CRT after induction chemotherapy has been performed for locally advanced head and neck cancer that cannot be operated immediately or for organ function preservation
The efficacy of induction chemotherapy before chemotherapy has been controversial because the results of several phase 3 clinical studies are inconsistent At present it is difficult to assert the superiority of either the addition of induction chemotherapy or radiation therapy alone but in certain subgroups advanced N stage such as N2cN3 induction chemotherapy is a useful option to lower distant metastases I can do it
As a result of the TAX324 clinical trial when weekly carboplatin-based chemotherapy or surgery was performed after adjuvant Docetaxel Cisplatin 5FU chemotherapy overall survival was improved compared to Cisplatin 5FU HR 07 p00058 It resulted in improvement of institutional retention rate 3 year LFS 52 vs 32 However it is difficult to apply this TPF therapy to all patients in actual clinical practice due to the toxicity neutropenia nephrotoxicity and the limitation of anticancer radiation
In a retrospective study in the case of adjuvant paclitaxel carboplatin there was no difference in progression-free survival compared to TPF p015 and there was no statistically significant decrease in the local recurrence rate HR 027 p 004 Confirmed
Therefore in this study when paclitaxel and carboplatin-induction chemotherapy followed by surgery and chemotherapy after surgery compared to standard TPF-induced chemotherapy it is expected that the clinical outcome will be improved with less toxicity
Hypothesis Paclitaxel and carboplatin-induction chemotherapy followed by surgery followed by chemo-radiation after surgery according to standard guidelines Compared with the existing standard treatment TCF improvement of clinical outcome with less toxicity
Study procedure
Induction chemotherapy Paclitaxel 175mgm2 Carboplatin AUC5 calculated by Cockcroft - Gault formula Combination therapy A total of 2 intravenous infusions every 3 weeks Surgery performed within 2-9 weeks after induction chemotherapy
surgery The surgery in this study means a complete resection for the purpose of a complete cure and aims for a minimally invasive surgery
Secondary objective To evaluate the efficacy and safety of induction chemotherapy Outcome metrics Local relapse rate LRR Relapse-free survival RFS Overall survival OS Adverse reactions according to CTCAE 50 Exploratory Purpose To evaluate changes in circulating tumor cells CTC and immunodynamics before and after paclitaxel and carboplatin-induction chemotherapy through blood biopsy specimens and surgical specimen analysis
background
Chemoradiation CRT or chemotherapy Induction Chemotherapy IC CRT after induction chemotherapy has been performed for locally advanced head and neck cancer that cannot be operated immediately or for organ function preservation
The efficacy of induction chemotherapy before chemotherapy has been controversial because the results of several phase 3 clinical studies are inconsistent At present it is difficult to assert the superiority of either the addition of induction chemotherapy or radiation therapy alone but in certain subgroups advanced N stage such as N2cN3 induction chemotherapy is a useful option to lower distant metastases I can do it
As a result of the TAX324 clinical trial when weekly carboplatin-based chemotherapy or surgery was performed after adjuvant Docetaxel Cisplatin 5FU chemotherapy overall survival was improved compared to Cisplatin 5FU HR 07 p00058 It resulted in improvement of institutional retention rate 3 year LFS 52 vs 32 However it is difficult to apply this TPF therapy to all patients in actual clinical practice due to the toxicity neutropenia nephrotoxicity and the limitation of anticancer radiation
In a retrospective study in the case of adjuvant paclitaxel carboplatin there was no difference in progression-free survival compared to TPF p015 and there was no statistically significant decrease in the local recurrence rate HR 027 p 004 Confirmed
Therefore in this study when paclitaxel and carboplatin-induction chemotherapy followed by surgery and chemotherapy after surgery compared to standard TPF-induced chemotherapy it is expected that the clinical outcome will be improved with less toxicity
Hypothesis Paclitaxel and carboplatin-induction chemotherapy followed by surgery followed by chemo-radiation after surgery according to standard guidelines Compared with the existing standard treatment TCF improvement of clinical outcome with less toxicity
Study procedure
Induction chemotherapy Paclitaxel 175mgm2 Carboplatin AUC5 calculated by Cockcroft - Gault formula Combination therapy A total of 2 intravenous infusions every 3 weeks Surgery performed within 2-9 weeks after induction chemotherapy
surgery The surgery in this study means a complete resection for the purpose of a complete cure and aims for a minimally invasive surgery
Detailed Description:
o Induction chemotherapy Paclitaxel 175mgm2 Carboplatin AUC5 calculated by Cockcroft - Gault formula Combination therapy A total of 2 intravenous infusions every 3 weeks
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