Status:
UNKNOWN
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
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Head and Neck Cancer
Radiation Toxicity
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy delivers thin beams of radiation of different strengths directly to the tumor from man...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00081029
Start Date
January 1 2004
Last Update
March 23 2011
Active Locations (9)
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1
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
2
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom, HU8 9HE
3
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
4
Barts and the London School of Medicine
London, England, United Kingdom, EC1M 6BQ