Concurrent Chemotherapy with Radiotherapy versus Radiotherapy alone in Head and Neck Cancer Patients

Not Applicable

Conditions: Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Registration Number: CTRI/2022/06/043259

Lead Sponsor: Jawarhalal Institute of Post Graduate Medical Education and Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Age : above 18 years less than 75 yrs.

2.Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx and hypopharynx.

3.Stage: cT4a, T4b, N1-3, M0, ECOG Performance status: 2-3, planned for palliative radiation.

Exclusion Criteria

1.Any patient with Stage: cT1-3, N1,2a,b,c, M0, ECOG PS: 0,1,

2.Abnormal renal (creatinine clearance <30 ml/min), hematological (grade 3-4 neutropenia and thrombocytopenia ) and liver function test (serum bilirubin > 1.5 times the normal upper limit) .

3.Cardiovascular abnormalities which includes prior history of myocardial infarction, angina, dysrhythmias,CAD , cardiac failure.

4.Recurrent tumors

5. Uncontrolled co-morbidities

6. Non squamous histopathology.

7.Prior history of radiation

8. Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the progression free survival (PFS) in both arms which include relapse of tumour (locoregional or distant), disease progression, development of second primary, death from any cause.Timepoint: After completion of radiation patient will be monitored after 6 weeks to look for toxicity and thereafter for 3 months by repeat CECT to look for tumour response followed by 6 months.

Secondary Outcome Measures

Name	Time	Method
1.To assess the overall response of the tumor in both arms assessed by contrast enhanced CT of the head and neck, 3 months post treatment . <br/ ><br>2.To assess the locoregional control in both arms assessed by contrast enhanced CT of the head and neck, 6 months and 1 year post treatment. <br/ ><br>3. To assess the overall survival in both arms. <br/ ><br>4. To compare the quality of life in both arms. <br/ ><br> 5. To assess the proportion of patients developing acute and late side effects of radiation. <br/ ><br>6. To assess the proportion of patients developing chemotherapy toxicity. <br/ ><br>7. To assess the time for development and resolution of each grade of toxicity in both the arms <br/ ><br>8. To assess the the proportion of patients requiring enteral feeding in both the arms <br/ ><br>9. To assess the proportion of patients who are tube dependent at 6 months in both the arms. <br/ ><br>10. To assess the compliance to treatment in both the arms. <br/ ><br>Timepoint: 6 months