Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01291095
First received: February 7, 2011
Last updated: March 3, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
HEAD AND NECK CANCER
Drug: CISPLATIN
Radiation: EXTERNAL BEAM RADIOTHERAPY
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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:
  • TO COMPARE POST-THERAPY QUALITY OF LIFE BETWEEN AFRT AND CRT IN LOCALLY ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA. [ Time Frame: 5months(2months treatment period followed by 3months observation) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: EBRT

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291095

Contacts
Contact: sudeep das, MBBS 00919350114969 sudeepdas1981@gmail.com
Contact: Dr BIDHU K MOHANTI, MD 00911126173045 drbkmohanti@rediffmail.com

Locations
India
Dr B.R.A.I.R.C.H, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI Recruiting
New Delhi, Other state, India, 110029
Contact: Dr SUDEEP DAS, MBBS    919350114969    sudeepdas1981@gmail.com   
Contact: Dr BIDHU K MOHANTI, MD    00911126173045    drbkmohanti@rediffmail.com   
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
  More Information

No publications provided

Responsible Party: DR SUDEEP DAS, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA
ClinicalTrials.gov Identifier: NCT01291095     History of Changes
Other Study ID Numbers: RCTOFAFRTVSCRTINHNSCCAIIMS
Study First Received: February 7, 2011
Last Updated: March 3, 2011
Health Authority: INDIA:ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014