Status:

UNKNOWN

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

Lead Sponsor:

Tata Memorial Hospital

Conditions:

Squamous Cell Carcinoma of the Head and Neck

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

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 radi...

Detailed Description

1.0 Introduction: 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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2009

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00652613

Start Date

August 1 2005

End Date

August 1 2009

Last Update

April 11 2008

Active Locations (1)

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1

Tata Memorial Hospital

Mumbai, Maharashtra, India, 400012