In this trial we are assessing the safety and efficacy and any difference in treatment outcome ââ?¬Å?Combination of Chemotherapy and External Radiation Therapy with 3 weeky and weekly Cisplatin.
- Conditions
- Health Condition 1: null- Locally advance Head and Neck Squamous Cell Carcinoma Cancer Patients
- Registration Number
- CTRI/2018/03/012422
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Newly diagnosed, chemo/radiotherapy na�¯ve, biopsy or cytology proven, locally advanced head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma (stage III and IV without distant metastases)
2.Patients who are considered suitable for either definitive chemo-radiation after discussion in combined clinic(HN clinic)
3.No evidence of distant metastases on clinical examination or on chest x-ray
4.Age 18-70 years
5.ECOG PS 0-2
6.No contraindication to Cisplatin or radiotherapy
7.Adequate organ function at time of participation, defined as
A. Hematological: Hemoglobin > 9gm/dl, ANC � 1500/cmm3, Platelet �100000/cmm3
B. Liver Function test: Bilirubin �2 x upper limit normal (ULN), AST/ALT/ ALP � 2.5 x ULN
C. Renal Function test: Creatinine � 1.5 ULN, Creatinine Clearance �60 ml/mins
1.Uncontrolled concomitant other systemic disease
2.History of moderate to severe hearing loss
3.History of previous malignancy excluding non-melanoma skin cancers or cervical carcinoma in situ
4.Documented Weight loss of more than 15% in last 6 months
5.Patients with known HIV, hepatitis B or C infection
6.Patients with known distant metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method