Phase II Randomized Controlled Trial of Accelerated Fractionation Radiotherapy (6 Fractions Per Week) Versus Concurrent Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- CISPLATIN
- Conditions
- HEAD AND NECK CANCER
- Sponsor
- All India Institute of Medical Sciences, New Delhi
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- TO COMPARE THE LOCO-REGIONAL TUMOR CONTROL RATE BETWEEN AFRT & CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMAS.
- Last Updated
- 15 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 20 - 60 years old
- •Karnofsky performance scale score 70 or above
- •Biopsy proven squamous cell carcinomas (SCC) of oropharynx, larynx and hypopharynx
- •TNM stages- Stage III -IVB
- •Informed consent (in prescribed form under institutional guidelines)
Exclusion Criteria
- •Lack of histopathological proof of malignancy (HNSCC)
- •Doubtful follow-up and/ or non-compliance
- •Previous oncologic therapy with surgery, radiotherapy or chemotherapy
- •Uncontrolled comorbid conditions e.g hypertension, diabetes mellitus, chronic obstructive pulmonary disease, coronary artery disease
Arms & Interventions
CONCURRENT CHEMO-RADIOTHERAPY ARM
Patients assigned to CRT arm will be given radiation one fraction per day, on five consecutive days from Monday to Friday along with intravenous cisplatin 40 mg/m2 weekly for seven doses (a minimum of 5weekly chemotherapy).
Intervention: CISPLATIN
CONCURRENT CHEMO-RADIOTHERAPY ARM
Patients assigned to CRT arm will be given radiation one fraction per day, on five consecutive days from Monday to Friday along with intravenous cisplatin 40 mg/m2 weekly for seven doses (a minimum of 5weekly chemotherapy).
Intervention: EXTERNAL BEAM RADIOTHERAPY
ACCELERATED FRACTIONATION RADIOTHERAPY ARM
Patients assigned to AFRT arm will undergo radiation similarly one fraction per day and then the sixth fraction will be given on another day (Saturday) or as an extra fraction on one of the first five days, but always allowing at least a 6-hour interval between fractions on same day. If any unintended interruption of the treatment occurs, this missing treatment will be given as soon as possible, preferably within a week, but not allowing more than 14 Gy to be given during any 7-day period.
Intervention: EXTERNAL BEAM RADIOTHERAPY
Outcomes
Primary Outcomes
TO COMPARE THE LOCO-REGIONAL TUMOR CONTROL RATE BETWEEN AFRT & CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMAS.
Time Frame: 5months(2months treatment period followed by 3 months observation)
To compare the loco-regional tumor control rate clinical assessment after 3months of treatment completion will be done.CECT of face and neck at 3 months post treatment completion will be done.
TO COMPARE THE TOXICITY BETWEEN AFRT AND CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMAS
Time Frame: 3 months(2 month treatment periods followed by 1month observation)
To compare toxicity weekly and at 1month post treatment completion hemogram will be done and assessed by CTCAE V3.0. Assessment of acute morbidity clinically will be done by CTCAE V-3.0 scoring system weekly, and post-RT 1 month.
Secondary Outcomes
- TO COMPARE POST-THERAPY QUALITY OF LIFE BETWEEN AFRT AND CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA.(5months(2months treatment period followed by 3months observation))