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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360978
• Other study ID #: docetaxel as a radiosenstizer
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Docetaxel
Our patients will receive docetaxel (15 mg per meter squared) once weekly concurrently with radiotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	Progression free survival defined as the average length of time after the start of treatment in which a person is alive and their cancer does not grow or spread	2 years
Secondary	incidence of treatment adverse events	evaluation of any adverse events will be occurred during treatment and 2 years after	2 years
Secondary	Overall survival (OS)	Overall survival defined as the average length of time patients are alive after diagnosis or the start of treatment.	2 years