A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer
N/A
N/A
Both
Head and Neck Cancer, Radiation Toxicity, Xerostomia
Trial Information
A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer
OBJECTIVES:
Primary
- Compare the proportion of patients with oropharyngeal or hypopharyngeal cancer with
xerostomia of ≥ grade 2 at one year after treatment with parotid-sparing
intensity-modulated radiotherapy vs conventional radiotherapy.
Secondary
- Compare the degree of xerostomia by quantitative measurements of stimulated and
unstimulated salivary flow in patients treated with these regimens.
- Compare quality of life in patients treated with these regimens.
- Compare local and regional tumor control, time to tumor progression, and overall
survival of patients treated with these regimens.
- Compare acute and late side effects of these regimens in these patients.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to participating center and site of disease (oropharynx vs hypopharynx). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo parotid-sparing intensity-modulated radiotherapy once daily, 5
days a week, for 6 weeks.
- Arm II: Patients undergo conventional radiotherapy once daily, 5 days a week, for 6
weeks.
Salivary flow measurements are performed at baseline, at week 4 during radiotherapy, and
then at 2 weeks and at 3, 6, 12, and 24 months after the completion of radiotherapy.
Quality of life is assessed at baseline, at 2 weeks, and then at 3, 6, 12, 18, and 24 months
after the completion of radiotherapy.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months
for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed oropharyngeal or hypopharyngeal cancer
- Squamous cell or undifferentiated carcinoma
- Stage T1-4, N0-3, M0 disease
- Primary tumor requiring radical radiotherapy with parallel opposed lateral fields and
bilateral cervical lymph node irradiation
- Radiotherapy is either the primary therapy or post-operative (adjuvant
irradiation) treatment
- High-risk for radiation-induced xerostomia with conventional radiotherapy due to
irradiation of the majority of both parotid glands* NOTE: *Estimated mean dose to
both parotid glands is greater than 24 Gy by conventional radiotherapy
- No bilateral N3 nodal disease
- No huge primary tumor (exceeding 10 cm in diameter)
- No contralateral lymphadenopathy adjacent to or involving contralateral parotid gland
making parotid sparing impossible
- No tumor at the base of the tongue where sparing of contralateral parapharyngeal
space is contraindicated
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Able to undergo quality of life and salivary flow measurements (dependent on
cognitive aptitude and long availability)
- Able to complete self-assessed quality of life questionnaire
- No prior or concurrent illness that would preclude study participation
- No pre-existing salivary gland pathology interfering with saliva production
- No other prior malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Prior neoadjuvant chemotherapy allowed
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy to the head and neck region
- No concurrent brachytherapy
Surgery
- See Disease Characteristics
Other
- No concurrent prophylactic amifostine or pilocarpine
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year
Safety Issue:
Yes
Principal Investigator
Chris Nutting
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000358803
NCT ID:
NCT00081029
Start Date:
January 2004
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Radiation Toxicity
- Xerostomia
- xerostomia
- radiation toxicity
- stage I squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the oropharynx
- Head and Neck Neoplasms
- Xerostomia
- Hypopharyngeal Neoplasms
- Radiation Injuries
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