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NCT Number: NCT00188877

Intensity Modulated Radiation Therapy for Head and Neck Cancer

Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. Standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells.

The doctors at Princess Margaret Hospital are conducting this study in order to test whether the use of IMRT techniques can improve the chance of controlling your cancer in the head and neck region.

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Key information

Conditions

Nasopharyngeal Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation
  • less than 70 yrs of age
  • Stage T1-T4; N0-N3; M0
  • KPS less than 70
  • no prior RT to H&N or chemotherapy for H&N
  • no other malignancy except non-melanomatous skin cancer
  • no distant mets
  • no contraindication to RT or chemotherapy
  • adequate organ function
  • informed consent

Exclusion criteria

  • Major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.

Treatment and study plan

Intensity Modulated Radiation Therapy

Procedure

cisplatinium and fluorouracil - standard treatment

Drug

Primary outcomes

  1. The primary objective of this study is to evaluate 3 year local progression free survival in patients with nasopharyngeal carcinoma treated with Intensity Modulated Radiation Therapy (IMRT) techniques.

    Time frame: q2 monthly during year 1, q3 monthly during year 2; q4 monthly during year 3; q6 monthly during year 4 and annually thereafter

Secondary outcomes

  1. -the ability of IMRT techniques to spare long term xerostomia as evaluated by saliva flow rates.

  2. -the nature and prevalence of acute and late side effects and their relationship to local dose.

  3. -the dosimetric differences between conventional "forward planned" two dimensional plans, three dimensional plans and Intensity modulated radiation therapy.

  4. -evaluation of failure with respect to the doses in the region of the failure

  5. -quality of life measurements in patients after receiving IMRT for the treatment of nasopharyngeal carcinoma

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

A Phase II Study of Intensity Modulated Radiation Therapy for Nasopharyngeal Cancer

Important dates

Study start
2003
Primary completion
2008
Study completion
2019
First posted
Sep 16, 2005
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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