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Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) Versus Intensity Modulated Radiotherapy (IMRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652613
Recruitment Status : Unknown
Verified April 2008 by Tata Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 4, 2008
Last Update Posted : April 11, 2008
Information provided by:
Tata Memorial Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Radiation: 3 Dimensional Radiation Therapy Radiation: Intensity Modulated Radiation Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : August 2005
Estimated Primary Completion Date : March 2008
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
3 dimensional conformal radiotherapy
Radiation: 3 Dimensional Radiation Therapy
Radiation with 6 MV photons to dose of 70Gy/ 35#/ 7 weeks

Experimental: 2
Intensity Modulated Radiation Therapy (IMRT)
Radiation: Intensity Modulated Radiation Therapy
IMRT with 6 MV photons to a dose of 66Gy/30#/ 6 weeks

Primary Outcome Measures :
  1. Major salivary gland sparing by 3-D CRT vis-à-vis IMRT. Assess adequacy of target volume coverage [ Time Frame: 4 yrs ]
  2. Determine the pattern of local and loco-regional recurrence [ Time Frame: 4 yrs ]

Secondary Outcome Measures :
  1. Disease Free Survival (DFS) and Overall Survival (OAS) [ Time Frame: 4 yrs ]
  2. Quality of life 3. Dose to OAR [ Time Frame: 4 yrs ]
  3. Assess the reduction in dose with IMRT to the normal larynx and normal pharyngeal constrictors in oropharyngeal cancers, uninvolved oral mucosa and auditory apparatus [ Time Frame: 4 yrs ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Biopsy proven squamous cell carcinoma of the oropharynx or laryngopharynx.
  • AJCC stage T1-3, NO-2b, MO patients with pre-treatment tumor measurements clinically as well as on CT/MRI scans.
  • Surgery of the primary tumor limited to excisional or incisional biopsy.
  • No form of neck dissection for nodal metastases.
  • KPS > 60 (see appendix I).
  • Age > 18 and < 65 years.
  • No prior history of therapeutic irradiation.
  • Patient willing and reliable for follow-up.
  • Patient's nutritional & physical condition compatible with planned therapy.

Exclusion Criteria:

  • Evidence of distant metastases.
  • Previous therapeutic irradiation for head & neck cancer or any other invasive cancer other than squamous or basal cell carcinoma of the skin.
  • History of prior malignancy.
  • Prophylactic use of amifostine or pilocarpine.
  • Active untreated infection like tuberculosis, which preclude the use of systemic chemotherapy or would interfere with completion of treatment.
  • Any histopathology other than Squamous Carcinoma.
  • Primary nasopharyngeal carcinoma.
  • Age < 18 or > 65 years.
  • Pregnancy or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652613

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Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
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Principal Investigator: Sarbani Ghosh-Laskar, MD Department of Radiation Oncology, Tata Memorial Centre
Study Director: Ketayun Dinshaw, FRCR Director, Tata Memorial Centre
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sarbani Ghosh-Laskar, Tata Memorial Centre Identifier: NCT00652613    
Other Study ID Numbers: H&N_3DCRT_IMRT07
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: April 2008
Keywords provided by Tata Memorial Hospital:
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
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site