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

Sponsor
All India Institute of Medical Sciences, New Delhi (Other)
Overall Status
Unknown status
CT.gov ID
NCT01291095
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
22
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Feb 1, 2011
Anticipated Primary Completion Date :
Jul 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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).

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
Other Names:
  • CDDP

    • 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.
    Other Names:
  • EBRT

    		•
    Experimental: 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.

    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.
    Other Names:
  • EBRT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr B.R.A.I.R.C.H, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI New Delhi Other state India 110029

    Sponsors and Collaborators

    • All India Institute of Medical Sciences, New Delhi

    Investigators

    • Principal Investigator: Dr SUDEEP DAS, MBBS, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01291095
    Other Study ID Numbers:
    • RCTOFAFRTVSCRTINHNSCCAIIMS
    First Posted:
    Feb 8, 2011
    Last Update Posted:
    Mar 4, 2011
    Last Verified:
    Mar 1, 2011
    Additional relevant MeSH terms:
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck
    Cisplatin

    Study Results

    No Results Posted as of Mar 4, 2011