• Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year [ Designated as safety issue: Yes ]
  

• Degree of xerostomia by salivary flow at 1 year [ Designated as safety issue: No ]
  
• Xerosomia-related quality of life by Modified Xerostomia questionnaire at 1 year [ Designated as safety issue: No ]
  
• Quality of Life by EORTC QLQ C30 v.3.0 and QLQ-H&N35 questionnaires at 1 year [ Designated as safety issue: No ]
  
• Local and regional tumor control by a quantitative description of sites of relapse at 1 year [ Designated as safety issue: No ]
  
• Time to tumor progression at 1 year [ Designated as safety issue: No ]
  
• Overall survival at 1 year [ Designated as safety issue: No ]
  
• Acuteside effects of radiotherapy by NCI CTCAE scale v. 3.0 at 1 year [ Designated as safety issue: Yes ]
  
• Late side effects of radiotherapy by NCI CTCAE scale v3.0, LENT SOMA and RTOG at 1 year [ Designated as safety issue: Yes ]
  

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.

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