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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


Phase 2
20 Years
60 Years
Open (Enrolling)
Both
HEAD AND NECK CANCER

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

5months(2months treatment period followed by 3 months observation)

Safety Issue:

No

Principal Investigator

Dr SUDEEP DAS, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

Authority:

INDIA:ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

Study ID:

RCTOFAFRTVSCRTINHNSCCAIIMS

NCT ID:

NCT01291095

Start Date:

February 2011

Completion Date:

December 2012

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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