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

NCT ID: NCT06360978

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2027-06-30

Brief 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.

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

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Docetaxel

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Osama Abdelmaboud

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

docetaxel as a radiosenstizer

Identifier Type: -

Identifier Source: org_study_id