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NCT06360978Not yet recruiting

Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer

Assiut UniversityPhase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Head and Neck Cancer
Drug/Device/Intervention
Docetaxel
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Assiut University
Timeline & enrollment
Phase
Phase 2
Start date
Apr 01, 2024
End date
Jun 01, 2027
Enrollment
30 participants
Primary outcome

progression free survival

Summary

Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more
 than 660,000 new cases and 325,000 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.

ICD-10 classifications
Malignant neoplasm of other and ill-defined sites: Head, face and neckMalignant neoplasm: Skin of scalp and neckMalignant neoplasm: Connective and soft tissue of head, face and neckCarcinoma in situ: Skin of scalp and neckSecondary and unspecified malignant neoplasm: Lymph nodes of head, face and neck
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06360978
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06360978 through Pure Global AI's free database. This Phase 2 trial is sponsored by Assiut University and is currently Not yet recruiting. The study focuses on Head and Neck Cancer. Target enrollment is 30 participants.

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