A comparison of radiation treatment given 6 days a week versus radiation treatment given 5 days a week along with three-weekly chemotherapy in advanced cancers of the head and neck expressing the EGFR mutatio
Phase 3
Completed
- Conditions
- Health Condition 1: null- EGFR overe expressed locally advanced squamous cell carcinoma of head and neck,
- Registration Number
- CTRI/2018/04/013311
- Lead Sponsor
- Government funded institution
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 61
Inclusion Criteria
1. Patients with histology proven EGFR overexpressed squamous cell carcinoma of head and neck region.
2. No previous chemotherapy of radiotherapy for head and neck cancer. 3. No previous surgery except biopsy. 4. Informed consent.
Exclusion Criteria
1. Evidence of systemic metastasis. 2.Histologically other than squamous cell carcinoma.
3. Pregnancy and lactation. 4. Evidence of uncontrolled co-morbidities like uncompensated renal, cardiac, hepatic and respiratory disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocal controlTimepoint: Local control after 6 weeks of completion of treatment.
- Secondary Outcome Measures
Name Time Method 1. Acute toxicities. 2. Late toxicities 3. Recurrence. 4. Death due to any cause.Timepoint: 1. Acute toxicities - weekly during treatment and 6 weeks after completion of treatment. 2. Late toxicities - every three monthly after 6 months of completion of treatment. 3. Recurrence - every three monthly after 6 months of completion of treatment. 4. Whenever the primary investigator get to know the news of death.