To hear about similar clinical trials, please enter your email below
Trial Title:
Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer
NCT ID:
NCT06360978
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Docetaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Our patients will receive docetaxel (15 mg per meter squared) once weekly concurrently
with radiotherapy.
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
Criteria for 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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06360978
