Oxaliplatin vs Cisplatin in Chemoradiotherapy of Head and Neck Cancer
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2019/01/017198
- Lead Sponsor
- AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
1.Histologically confirmed locally advanced head and neck squamous cell cancers.
2.Stage III-IVB by AJCC Cancer Staging Manual Eight Edition, 2017.
3.Primary tumour sites in oral cavity, oropharynx, hypopharynx and larynx.
4.Age >18 years and <70 years.
5.Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
6.Haemoglobin > 10g/L.
7.Total Leucocyte count > 4,000/cumm.
8.Platelet count > 1,00,000/cumm.
9.Bilirubin <1.5mg/dL, SGOT and SGPT < 3Ã? upper limit.
10.Normal Serum creatinine and Blood Urea.
11.Patients who had not received prior chemotherapy and/or radiotherapy.
1.Synchronous malignancy.
2.Previously diseased salivary gland.
3.Patients with history of neuropathy e.g. Diabetic neuropathy
4.Patients with Congestive cardiac failure.
5.Patients with uncontrolled hypertension.
6.Patients not willing for concurrent chemoradiotherapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % of tumour responseTimepoint: 3 months and 6 months
- Secondary Outcome Measures
Name Time Method Compliance of concurrent oxaliplatin with radiotherapy in locally advanced non-nasopharyngeal head and neck cancer.Timepoint: During treatment;To compare disease control at 6 months with concurrent chemoradiotherapy using oxaliplatin versus concurrent chemoradiotherapy using cisplatin in locally advanced non-nasopharyngeal head and neck cancer.Timepoint: 6 months;To compare the toxicity profile of concurrent chemoradiotherapy using oxaliplatin versus concurrent chemoradiotherapy using cisplatin in locally advanced non-nasopharyngeal head and neck cancers.Timepoint: Weekly review during treatment. <br/ ><br>