Accelerated Fractionation Radiotherapy (AFRT) Versus Concurrent Chemoradiotherapy (Crt) In Locally Advanced Head And Neck Squamous Cell Carcinoma
Conditions
HEAD AND NECK CANCER
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CISPLATIN Type: Drug
Name: EXTERNAL BEAM RADIOTHERAPY Type: Radiation
Overall Status
Recruiting
Summary
The aim of this trial is to compare the accelerated fractionation radiotherapy and concurrent chemo-radiotherapy in locally advanced head and neck squamous cell carcinoma patients in terms of loco-regional control, toxicities and quality of life.
Detailed Description
Concurrent chemo-radiotherapy is a common and conventional method of treating locally advanced head and neck squamous cell carcinoma (HNSCC). In locally advanced HNSCC it has been proved to be superior to radiotherapy alone. On the other side accelerated fractionation radiotherapy (AFRT) is a proven practice to improve cure rate in head and neck cancers. Yet it has not been compared with Concurrent Chemoradiotherapy (CRT) in locally advanced HNSCC and hence this study is aiming to compare CRT versus AFRT.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Age: 20 - 60 years old

2. Karnofsky performance scale score 70 or above

3. Biopsy proven squamous cell carcinomas (SCC) of oropharynx, larynx and hypopharynx

4. TNM stages- Stage III -IVB

5. Informed consent (in prescribed form under institutional guidelines)

Exclusion Criteria:

1. Lack of histopathological proof of malignancy (HNSCC)

2. Doubtful follow-up and/ or non-compliance

3. Previous oncologic therapy with surgery, radiotherapy or chemotherapy

4. Uncontrolled comorbid conditions e.g hypertension, diabetes mellitus, chronic obstructive pulmonary disease, coronary artery disease
Location
Dr B.R.A.I.R.C.H, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
New Delhi, Other state, India
Status: Recruiting
Contact: Dr SUDEEP DAS, MBBS - 919350114969 - sudeepdas1981@gmail.com
Start Date
February 2011
Completion Date
December 2012
Sponsors
All India Institute of Medical Sciences, New Delhi
Source
All India Institute of Medical Sciences, New Delhi
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page