Know Cancer

forgot password

A Phase I/II Feasibility Study Using Intensity-modulated Radiation Therapy in Patients With Nasopharynx Cancer to Permit Sparing of Contralateral Parotid Gland Function

Phase 1/Phase 2
18 Years
Not Enrolling
Nasopharyngeal Neoplasms

Thank you

Trial Information

A Phase I/II Feasibility Study Using Intensity-modulated Radiation Therapy in Patients With Nasopharynx Cancer to Permit Sparing of Contralateral Parotid Gland Function

Radiotherapy is the primary treatment modality for patients with nasopharyngeal carcinoma,
with local control being directly related to dose and to the technical accuracy with which
the dose is delivered to the target volume. Treatment planning for nasopharyngeal carcinoma
is complicated by the presence of many critical structures (spinal cord, brainstem, temporal
lobe, optic chiasm and nerves, parotid glands, etc.) adjacent to the primary target volume
(primary cancer), which itself requires a higher prescription dose for good probability of
local control than the tolerance doses for any of these adjacent organs at risk.
Conventional, traditional radiotherapy has therefore involved treating the adjacent organs
at risk to tolerance (e.g. spinal cord) or even above tolerance (e.g. parotid gland) to
achieve a reasonable chance of locoregional control, leaving the patient with significant
acute and late normal tissue toxicity that impacts both ability to tolerate the actual
treatment and on the patient's long-term quality of life. Recently, static conformal
multisegmental intensity modulated radiotherapy for comprehensive irradiation of head and
neck cancer with dose sparing of uninvolved tissues has been reported (Eisbruch et al.,
1996). These authors have demonstrated substantial preservation of major salivary gland
function using these techniques for primary sites in the oral pharynx, oral cavity,
epiglottic larynx and pyriform sinus, which would be expected to significantly improve
long-term quality of life, as a permanent xerostomia is the most prevalent late side effect
of irradiation for head and neck cancers and is cited by patients as the major cause of
decreased quality of life reported. To date, these techniques have not been described in the
published literature for nasopharyngeal carcinoma. Such techniques offer the possibility of
significant improvement in normal tissue toxicity, while maintaining possibly better rates
of local control due to improved target localization. The primary objective of this study is
to evaluate whether the intensity modulated radiotherapy can reduce the incidence of
permanent xerostomia in N0 and N1 nasopharynx cancer patients by sparing the contralateral
parotid gland, while delivering full dose to all known and suspected areas of disease.
Patients on study will receive 70 Gy given in 2 Gy once daily fractionation five days a week
to all grossly involved areas, and 50 Gy given in 2 Gy once daily fractionation five days a
week to areas at 15% or more risk of subclinical microscopic involvement. Patients will have
subjective and objective assessment of salivary gland function done prior to, during, and
after radiotherapy. Toxicity evaluation using the acute and chronic RTOG grading scales will
be done. The primary endpoint of this study is the frequency of grade 2 chronic salivary
gland toxicity. Correlation between toxicity and quality of life will be assessed. The
hypothesis that the use of IMRT can reduce grade 2 or worse chronic xerostomia by 50%
relatively will be tested. The required sample size for 90% statistical power and one-sided
type one error of 0.05 is 13 patients. This assumes that the contralateral parotid sparing
approach will have 40% grade 2 or more chronic xerostomia, whereas the population of
conventionally treated nasopharynx patients has 80% grade 2 or more chronic xerostomia.
Additional patients are added for possible ineligibility and inevaluability. A total of 18
patients will be accrued for this study. A significant survival advantage to concurrent
cisplatin-based chemoradiation plus adjuvant chemotherapy for nasopharyngeal cancer was
demonstrated recently in the published results of Intergroup Study 0099 (Al-Sarrf et al.,
1998) but this study used conventional radiotherapy techniques that did not incorporate
recent refinements to radiation planning now available using image-guided beam's-eye-view
modeling and 3-dimensional dose distributions. For the purposes of this study, concurrent
chemoradiation and adjuvant chemotherapy as per the experimental arm of Intergroup Study
0099 will be considered standard management, so that patients who accepted this treatment
would be eligible for this study.

Inclusion Criteria:

- Epithelial carcinoma of the nasopharynx, oral cavity, oropharynx, larynx, or

Exclusion Criteria:

- Previous therapy for carcinoma of head/neck

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

rate of grade 2 xerostomia

Principal Investigator

Matthew Parliament, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cross Cancer Institute


Canada: Health Canada

Study ID:




Start Date:

January 2000

Completion Date:

Related Keywords:

  • Nasopharyngeal Neoplasms
  • intensity modulated radiation therapy
  • parotid
  • nasopharyngeal carcinoma
  • Neoplasms
  • Nasopharyngeal Neoplasms