Health Condition 1: C109- Malignant neoplasm of oropharynx,unspecified
Conditions
Interventions
Intervention1: SMART RADIOTHERPY: THE FOLLOWING DOSES WILL BE PRESCRIBED
PTV HR 64GY/25 FRACTIONS AT 2.56 GY PER FRACTION
PTV IR 56 GY/25 FRACTIONS AT 2.24 GY PER FRACTION
PTV LR 50GY/25 FRACTIONS AT
Sponsors
JIPMER
Eligibility
Inclusion criteria
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 iii. Renal Function test: Creatinine =60 ml/mins iv. Magnesium >= lower limit of normal
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
Public ContactDrPooja Sethi
RegionalCancer Centre, JIPMER
Outcome results
None listed