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Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer - Trial NCT06360978

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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NCT06360978
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06360978
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Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer

Study Focus

Head and Neck Cancer

Docetaxel

Interventional

drug

Sponsor & Location

Assiut University

Timeline & Enrollment

Phase 2

Apr 01, 2024

Jun 01, 2027

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 neck
Malignant neoplasm: Skin of scalp and neck
Malignant neoplasm: Connective and soft tissue of head, face and neck
Carcinoma in situ: Skin of scalp and neck
Secondary and unspecified malignant neoplasm: Lymph nodes of head, face and neck

Data Source

ClinicalTrials.gov

NCT06360978

Non-Device Trial