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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Tata Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00652613
First received: March 27, 2008
Last updated: April 9, 2008
Last verified: April 2008
  Purpose

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
Squamous Cell Carcinoma of the Head and Neck
Radiation: 3 Dimensional Radiation Therapy
Radiation: Intensity Modulated Radiation Therapy
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 Study of 3-Dimensional Conformal Radiotherapy (3D-CRT) vs Intensity Modulated Radiotherapy (IMRT) for Squamous Cell Carcinoma of the Head and Neck (HNSCC)

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

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

Secondary Outcome Measures:
  • Disease Free Survival (DFS) and Overall Survival (OAS) [ Time Frame: 4 yrs ] [ Designated as safety issue: Yes ]
  • Quality of life 3. Dose to OAR [ Time Frame: 4 yrs ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00652613

Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Sarbani Ghosh-Laskar, MD Department of Radiation Oncology, Tata Memorial Centre
Study Director: Ketayun Dinshaw, FRCR Director, Tata Memorial Centre
  More Information

No publications provided

Responsible Party: Sarbani Ghosh-Laskar, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT00652613     History of Changes
Other Study ID Numbers: H&N_3DCRT_IMRT07
Study First Received: March 27, 2008
Last Updated: April 9, 2008
Health Authority: India: Institutional Review Board

Keywords provided by Tata Memorial Hospital:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on September 30, 2014