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

HEAD AND NECK CANCER Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01291095
• Other study ID #: RCTOFAFRTVSCRTINHNSCCAIIMS
• Status: Recruiting
• Phase: Phase 2
• First received: February 7, 2011
• Last updated: March 3, 2011
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2011
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: sudeep das, MBBS
• Phone: 00919350114969
• Email: sudeepdas1981[@]gmail.com
• Is FDA regulated: No
• Health authority: INDIA:ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• HEAD AND NECK CANCER
• Head and Neck Neoplasms

Intervention

Drug:
• CISPLATIN
IN CRT ARM:RADIATION ONE FRACTION PER DAY, ON FIVE CONSECUTIVE DAYS FROM MONDAY TO FRIDAY ALONG WITH INTRAVENOUS CISPLATIN 40mg/m2 WEEKLY FOR SEVEN DOSES. IN AFRT ARM: PATIENTS WILL NOT RECEIVE ANY CHEMOTHERAPY WITH CISPLATIN

Radiation:
• 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). 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.

Locations

Country	Name	City	State
India	Dr B.R.A.I.R.C.H, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI	New Delhi	Other state

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TO COMPARE THE LOCO-REGIONAL TUMOR CONTROL RATE BETWEEN AFRT & CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMAS.	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.	5months(2months treatment period followed by 3 months observation)	No
Primary	TO COMPARE THE TOXICITY BETWEEN AFRT AND CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMAS	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.	3 months(2 month treatment periods followed by 1month observation)	No
Secondary	TO COMPARE POST-THERAPY QUALITY OF LIFE BETWEEN AFRT AND CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA.	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).	5months(2months treatment period followed by 3months observation)	No