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

NCT06360978 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: docetaxel as a radiosenstizer
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• incidence of treatment adverse events

  2 years

• Overall survival (OS)

  2 years

Interventions

Docetaxel DRUG

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 18 years
• Pathologically proven of squamous cell carcinoma
• Patients with locally advanced disease (T3, T4)(N positive)
• Patients eligible for radiotherapy

You may not qualify if:

• Patients with metastatic disease
• Patients with second primary cancer
• Patients ineligible for radiotherapy

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share