Accelerated Fractionation Radiotherapy (AFRT) Versus Concurrent Chemoradiotherapy (Crt) In Locally Advanced Head And Neck Squamous Cell Carcinoma

Phase 2

• Conditions: HEAD AND NECK CANCER
• Interventions: Drug: CISPLATIN; Radiation: EXTERNAL BEAM RADIOTHERAPY

• Registration Number: NCT01291095
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-03
• Last Update Posted: 2011-03-04
• Primary Completion: 2012-07
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONCURRENT CHEMO-RADIOTHERAPY ARM	CISPLATIN	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).
CONCURRENT CHEMO-RADIOTHERAPY ARM	EXTERNAL BEAM RADIOTHERAPY	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).
ACCELERATED FRACTIONATION RADIOTHERAPY ARM	EXTERNAL BEAM RADIOTHERAPY	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.

Primary Outcome Measures

Name	Time	Method
TO COMPARE THE LOCO-REGIONAL TUMOR CONTROL RATE BETWEEN AFRT & CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMAS.	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	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 Outcome Measures

Name	Time	Method
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)	TO COMPARE THE POST-THERAPY QUALITY OF LIFE BETWEEN AFRT AND CRT IN LOCALLY ADVANCED HNSCC.Assessment of quality of life in patients in both arms will be recorded prior to start of treatment(for base-line record) and subsequently at 1month and 3months after treatment completion using European organization for research and treatment in cancer, Belgium quality of life questionnaire (EORTC QLQ-C30 \& QLQ-H\&N35).

Trial Locations

Locations (1)

Dr B.R.A.I.R.C.H, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI; 🇮🇳 New Delhi, Other state, India