Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia
Head and Neck Cancer, Radiation Toxicity, Xerostomia
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- Addenbrooke's Hospital
- Princess Royal Hospital at Hull and East Yorkshire NHS Trust
- Ipswich Hospital
- Barts and the London School of Medicine
- Royal Marsden - London
- University College Hospital - London
- Christie Hospital
- Cancer Research Centre at Weston Park Hospital
- University Hospital of North Staffordshire