Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05527782
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2022-08-31
Brief Title:
Induction Modified TPF Followed by Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Hospital Universitario Doctor Peset
Organization:
Hospital Universitario Doctor Peset
Study Overview
Official Title:
A Phase II Study of Efficacy and Safety of Induction Modified TPF mTPF Followed by Concurrent Chemoradiotherapy CCRT in Locally Advanced Squamous Cell Carcinoma of the Head and Neck LASCCHN
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The purpose of the study is to evaluate the efficacy and safety of induction mTPF chemotherapy followed by concurrent chemoradiotherapy for locally advanced squamous cell carcinoma of the head and neck cancer
Detailed Description:
The prognosis of patients with locally advanced squamous cell carcinoma of the head and neck LASCCHN is poor therefore continuous research effort is being made in order to improve treatment efficacy Standard treatment consists of concurrent chemoradiotherapy CCRT with cisplatin In spite of many clinical trials and meta-analyses the improvement of patient outcomes with the use of induction chemotherapy IC hasnt been clearly demonstrated partially due to the high toxicity of the standard TPF docetaxelcisplatinfluorouracil regimen used most frequently in this setting Therefore the aim of this study is to evaluate the outcomes of patients with LASCCHN treated with a less toxic induction mTPF regimen followed by CCRT
The study will include patients with LASCCHN who - by the decision of the multidisciplinary team - have been assigned treatment with IC followed by CCRT After being informed about the study objectives and potential risks all patients giving written informed consent and meeting all the eligibility criteria will start the treatment According to the study protocol participants will receive 4 cycles of induction mTPF regimen repeated every 2 weeks followed by computed tomography CT response evaluation 3-6 weeks after having completed the last cycle of mTPF patients without disease progression will start CCRT with 2 cycles of cisplatin every 3 weeks Twelve weeks after radiotherapy termination a PET-CT scan will be performed in order to evaluate the treatment outcome
The study will include patients with LASCCHN who - by the decision of the multidisciplinary team - have been assigned treatment with IC followed by CCRT After being informed about the study objectives and potential risks all patients giving written informed consent and meeting all the eligibility criteria will start the treatment According to the study protocol participants will receive 4 cycles of induction mTPF regimen repeated every 2 weeks followed by computed tomography CT response evaluation 3-6 weeks after having completed the last cycle of mTPF patients without disease progression will start CCRT with 2 cycles of cisplatin every 3 weeks Twelve weeks after radiotherapy termination a PET-CT scan will be performed in order to evaluate the treatment outcome
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?:
False
Is an FDA AA801 Violation?:
None