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Sponsored by: |
Tata Memorial Hospital |
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Information provided by: | Tata Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00652613 |
Head & Neck squamous cell carcinomas are the commonest cancers afflicting the developing countries. Traditionally surgery or radiotherapy alone in the early stages and surgery with postoperative radiotherapy in advanced stages have been the mainstay of treatment. Of late there has been a paradigm shift in the management of these cancers, particularly those of the oropharynx and laryngopharynx, where chemoradiation has been advocated as part of organ preservation protocol with good outcomes. Conventional radiotherapy involves the use of 2 or 3 field technique with or without compensators to encompass the volume at risk to radical doses of 66-70 Gy typically needed to sterilize gross disease. This strategy however is associated with considerable acute morbidity (mucositis, dysphagia, dermatitis) and debilitating late toxicity (xerostomia). Three dimensional conformal radiation therapy (3D-CRT) and intensity modulated radiation therapy (IMRT) have the potential to improve the dose distribution, with increased doses to the target volumes and reduced doses to surrounding normal structures, thereby improving the therapeutic ratio.
Condition | Intervention | Phase |
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Squamous Cell Carcinoma of the Head and Neck |
Radiation: 3 Dimensional Radiation Therapy Radiation: Intensity Modulated Radiation Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) vs Intensity Modulated Radiotherapy (IMRT) for Squamous Cell Carcinoma of the Head and Neck (HNSCC) |
Enrollment: | 60 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
3 dimensional conformal radiotherapy
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Radiation: 3 Dimensional Radiation Therapy
Radiation with 6 MV photons to dose of 70Gy/ 35#/ 7 weeks
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2: Experimental
Intensity Modulated Radiation Therapy (IMRT)
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Radiation: Intensity Modulated Radiation Therapy
IMRT with 6 MV photons to a dose of 66Gy/30#/ 6 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Maharashtra | |
Tata Memorial Hospital | |
Mumbai, Maharashtra, India, 400012 |
Principal Investigator: | Sarbani Ghosh-Laskar, MD | Department of Radiation Oncology, Tata Memorial Centre |
Study Director: | Ketayun Dinshaw, FRCR | Director, Tata Memorial Centre |
Responsible Party: | Tata Memorial Centre ( Sarbani Ghosh-Laskar ) |
Study ID Numbers: | H&N_3DCRT_IMRT07 |
Study First Received: | March 27, 2008 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00652613 |
Health Authority: | India: Institutional Review Board |
3DCRT IMRT HNSCC Quality of life |
Major salivary gland sparing Pattern of local and loco-regional recurrence Disease Free Survival (DFS) & Overall Survival (OAS) Dose reduction to normal structures with IMRT |
Epidermoid carcinoma Squamous cell carcinoma Carcinoma, squamous cell Quality of Life Neoplasms, Squamous Cell Carcinoma, Squamous Cell |
Salivary Gland Diseases Carcinoma, squamous cell of head and neck Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type |