Docetaxel is used with radiation therapy for treating advanced head and neck cancer when Cisplatin cannot be used.
Not Applicable
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2024/05/066839
- Lead Sponsor
- Jawaharlal Nehru Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Histopathologically proven squamous cell carcinoma of head & neck cancer patients.
Patient is a candidate for concurrent Chemoradiation.
Unsuitable for cisplatin due to Calculated Creatinine clearance less than 50 ml per min or
Hearing loss or tinnitus grade greater than 3 or
Allergy to agents that contain platinum.
Exclusion Criteria
History of previous malignancy. Previous irradiation. Distant metastasis. Presence of immunodeficiency syndromes.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate the adverse event profile and compliance of docetaxel with radiation in cisplatin-ineligible patientsTimepoint: 7 weeks
- Secondary Outcome Measures
Name Time Method Assess 1yr Disease Free Survival <br/ ><br>Timepoint: 1 year;Assess 1yr Overall Survival <br/ ><br>Timepoint: 1 year;Estimate the compliance of patients with Radiation- 90% completion rate and Concurrent Chemotherapy (Docetaxel)- 5 or more cycles <br/ ><br>Timepoint: 7 weeks;Estimate the rate of any grade adverse eventTimepoint: 7 weeks;Estimate the rate of grade 3 or above adverse events <br/ ><br>Timepoint: 7 weeks;Evaluate the number of Hospital admissions during the course of treatment <br/ ><br>Timepoint: 7 weeks;Evaluate the percentage of Interruptions during the course of treatmentTimepoint: 7 weeks