Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360978
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-29
Brief Title:
Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Head and neck cancer HNC is the seventh most common cancer globally accounting for more than 660000 new cases and 325000 deaths annually The overall incidence of HNC continues to rise with a predicted 30 increase annually by 2030 this increase has been recorded across both developed and developing countries
Approximately 90 of HNCs are squamous cell carcinoma The major risk factors of head and neck squamous cell carcinoma HNSCC are tobacco and heavy alcohol use and human papillomavirus infection There has been a significant decline in smoking in high-income countries during the last few decades which has led to a sharp decline in smoking related HNSCC While increase in global incidence of human papillomavirus HPV-associated or positive HNSCC Head and neck squamous cell carcinoma HNSCC is a highly challenging cancer despite the advancements in treatment the overall prognosis for HNSCC remains poor with a five-year survival rate of around 50
Chemoradiation is one of the treatment options for locally advanced head and neck cancers the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy CRT is the standard of care for locally advanced head and neck squamous cell carcinoma LAHNSCC cisplatin is contraindicated in many patients because of age diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group
The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC
Approximately 90 of HNCs are squamous cell carcinoma The major risk factors of head and neck squamous cell carcinoma HNSCC are tobacco and heavy alcohol use and human papillomavirus infection There has been a significant decline in smoking in high-income countries during the last few decades which has led to a sharp decline in smoking related HNSCC While increase in global incidence of human papillomavirus HPV-associated or positive HNSCC Head and neck squamous cell carcinoma HNSCC is a highly challenging cancer despite the advancements in treatment the overall prognosis for HNSCC remains poor with a five-year survival rate of around 50
Chemoradiation is one of the treatment options for locally advanced head and neck cancers the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy CRT is the standard of care for locally advanced head and neck squamous cell carcinoma LAHNSCC cisplatin is contraindicated in many patients because of age diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group
The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC
Detailed Description:
History age gender comorbidities and risk factors
Baseline evaluation of the patients
CT or MRI head and neck Endoscopy and biopsy will be taken Laboratory CBC renal functions and liver functions Nutritional assessment Audiogram as baseline assessment Dental assessment
Our patients will receive docetaxel 15 mg per meter squared once weekly concurrently with radiotherapy
Follow up of the patient during the course of treatment including evaluation of the patients weekly to assess the adverse events in the form of skin toxicity mucositis neutropenia and renal function affection
Follow up after finishing the course of treatment After 6 to 8 weeks the patient will be evaluated with CT or MRI head and neck and endoscopy Then every three month we will evaluate the patient as regarding the quality of life and late toxicity up to 2 years
Baseline evaluation of the patients
CT or MRI head and neck Endoscopy and biopsy will be taken Laboratory CBC renal functions and liver functions Nutritional assessment Audiogram as baseline assessment Dental assessment
Our patients will receive docetaxel 15 mg per meter squared once weekly concurrently with radiotherapy
Follow up of the patient during the course of treatment including evaluation of the patients weekly to assess the adverse events in the form of skin toxicity mucositis neutropenia and renal function affection
Follow up after finishing the course of treatment After 6 to 8 weeks the patient will be evaluated with CT or MRI head and neck and endoscopy Then every three month we will evaluate the patient as regarding the quality of life and late toxicity up to 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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