Clinical trial

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

Name
docetaxel as a radiosenstizer
Description
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.
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-06-01
Trial end
2027-06-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Docetaxel
Our patients will receive docetaxel (15 mg per meter squared) once weekly concurrently with radiotherapy.
Size
30
Primary endpoint
progression free survival
2 years
Eligibility criteria
Inclusion Criteria: * Patients above 18 years * Pathologically proven of squamous cell carcinoma * Patients with locally advanced disease (T3, T4)(N positive) * Patients eligible for radiotherapy Exclusion Criteria: * Patients with metastatic disease * Patients with second primary cancer * Patients ineligible for radiotherapy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-04-11

1 organization

1 drug

1 indication

Organization
Assiut University