Prospective study to evaluate the efficacy and toxicity of Simultaneous Modulated Accelerated Radiotherapy (SMART) in intermediate and high risk oropharyngeal squamous cell carcinoma - SMART

JIPMER0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•I .Newly diagnosed, chemo/radiotherapy naÃ¯ve, biopsy or cytology proven, intermediate and high risk advanced oropharyngeal squamous cell carcinoma, with an Multidisciplinary team recommendation (Head & Neck Tumour Clinic) for definitive concurrent chemo-radiotherapy
•Intermediate risk:
•i)HPV positive, Smokers ( >10 pack years of tobacco) and/or High nodal stage (N2-3)
•ii)HPV negative , non smoker with T2/T3 stage
•iii) HPV negative, smoker with T2/T3 stage
•iv) HPV negative and T4/high nodal stage (N2b-N3)
•II.Age 18-60 years
•III.Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•1V.Adequate organ function at time of participation, defined as
•i.Hematological: Hemoglobin > 9gm/dl, ANC >= 1500/mm3, Platelet >=100000/mm3
•ii.Liver Function test: Bilirubin <=2 x upper limit normal (ULN), AST/ALT/ ALP <= 2.5 x ULN, PT < 1.5 X ULN or International Normalised Ratio <=1. 5
•iii.Renal Function test: Creatinine <= 1.5 X ULN, Creatinine Clearance >=60 ml/mins
•iv.Magnesium >= lower limit of normal

•I.Uncontrolled concomitant other systemic disease
•II.Prior irradiation to the head and neck region
•III.Patients with known HIV, hepatitis B or C infection Any medical or surgical condition precluding chemotherapy/radiotherapy
•IV.History of prior malignancy or any form of prior oncological management in previous 5 years
•V.Patients with known distant metastases
•VI.Evidence of moderate to severe hearing loss (as per Pure tone audiometry (PTA)
•VII.Pregnancy

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