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
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer; Radiation Toxicity; Xerostomia
Intervention: management of therapy complications (Procedure); radiation therapy (Radiation)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Royal Marsden NHS Foundation Trust Official(s) and/or principal investigator(s): Chris Nutting, Study Chair, Affiliation: Royal Marsden NHS Foundation Trust
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 many angles. This type of radiation therapy may reduce
damage to the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality
of life. It is not yet known whether intensity-modulated radiation therapy is more effective
than conventional radiation therapy in preventing xerostomia and improving quality of life
in patients who have throat cancer.
PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy
to see how well it works compared to conventional radiation therapy in treating patients
with oropharyngeal or hypopharyngeal cancer who are at risk of developing xerostomia caused
by radiation therapy.
Clinical Details
Official title: A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer
Study design: Allocation: Randomized, Primary Purpose: Treatment
Primary outcome: Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year
Secondary outcome: Degree of xerostomia by salivary flow at 1 yearXerosomia-related quality of life by Modified Xerostomia questionnaire at 1 year Quality of Life by EORTC QLQ C30 v.3.0 and QLQ-H&N35 questionnaires at 1 year Local and regional tumor control by a quantitative description of sites of relapse at 1 year Time to tumor progression at 1 year Overall survival at 1 year Acuteside effects of radiotherapy by NCI CTCAE scale v. 3.0 at 1 year Late side effects of radiotherapy by NCI CTCAE scale v3.0, LENT SOMA and RTOG at 1 year
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 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Addenbrooke's Hospital, Cambridge, England CB2 2QQ, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust, Hull, England HU8 9HE, United Kingdom
Ipswich Hospital, Ipswich, England IP4 5PD, United Kingdom
Barts and the London School of Medicine, London, England EC1M 6BQ, United Kingdom
Royal Marsden - London, London, England SW3 6JJ, United Kingdom
University College Hospital - London, London, England WC1E 6AU, United Kingdom
Christie Hospital, Manchester, England M20 4BX, United Kingdom
Cancer Research Centre at Weston Park Hospital, Sheffield, England S1O 2SJ, United Kingdom
University Hospital of North Staffordshire, Stoke-On-Trent, England ST4 7LN, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2004
Last updated: March 22, 2011
|