SMART in intermediate and high risk Oropharyngeal Squamous cell carcinoma

Phase 2

• Conditions: Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified

• Registration Number: CTRI/2021/03/031644
• Lead Sponsor: JIPMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

I .Newly diagnosed, chemo/radiotherapy naïve, 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

High risk:

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the complete response rates at 3 months, in patients receiving Simultaneous Modulated Accelerated Radiotherapy(SMART) for intermediate and high risk oropharyngeal Squamous cell carcinoma.Timepoint: To assess the complete response rates at 3 months, in patients receiving Simultaneous Modulated Accelerated Radiotherapy(SMART) for intermediate and high risk oropharyngeal Squamous cell carcinoma.

Secondary Outcome Measures

Name	Time	Method
a)To assess the severity and to determine the proportion of early toxicities during and within 3 months of treatment and delayed radiation toxicities with minimum 1year follow-up.Timepoint: a)To assess the severity and to determine the proportion of early toxicities during and within 3 months of treatment and delayed radiation toxicities with minimum 1year follow-up.;b)To determine EFS Rate (Event Free Survival), DFS Rate (Disease Free Survival) and OS Rate (Overall Survival) with minimum 1year follow-up.Timepoint: b)To determine EFS Rate (Event Free Survival), DFS Rate (Disease Free Survival) and OS Rate (Overall Survival) with minimum 1year follow-up.;c)To assess the Quality of life (QOL) of patients receiving treatment at baseline, post treatment at the end of 3 months and 1 year.Timepoint: c)To assess the Quality of life (QOL) of patients receiving treatment at baseline, post treatment at the end of 3 months and 1 year.