Treatment outcome in head and neck cancer patients receiving carboplatin plus capecitabine based versus high dose cisplatin based chemoradiotherapy.
Phase 2
Completed
- Conditions
- Health Condition 1: C140- Malignant neoplasm of pharynx, unspecified
- Registration Number
- CTRI/2020/11/029290
- Lead Sponsor
- Govt Kilpauk Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 81
Inclusion Criteria
1. Histopathologically confirmed cases of head and neck squamous cell cancer
2. Performance status: ECOG scale 0 to 2.
3. Normal hemogram: i.e Hb.10%, TLC >4000/cumm, platelet count >100,000/cu mm.
4. Creatinine clearance >50ml/min
Exclusion Criteria
1. Patients not willing to participate in the study
2. Non squamous head and neck cancer
3. Uncontrolled diabetes, hypertension, acute or chronic kidney disease, congestive cardiac failure
4. HIV, HBV, HCV reactive disease
5. Concomitant administration of other experimental drugs
6. Previous radiotherapy to head and neck region
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Objective early treatment response (using RECIST v.1.1) <br/ ><br>2. Progression free survivalTimepoint: 1. Objective early treatment response will be evaluated at 6 months after treatment completion <br/ ><br>2. Progression free survival will be assessed keeping patients on two monthly followup
- Secondary Outcome Measures
Name Time Method 1. Grade 3 or higher treatment toxicities <br/ ><br>2. Duration of treatment interruption due to treatment related toxicitiesTimepoint: Both of the above parameters will be recorded during the treatment period