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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


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 year

Xerosomia-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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.



- 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


- Not specified


- Not specified


- Not specified


- 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


- Not specified


- Prior neoadjuvant chemotherapy allowed

- No concurrent chemotherapy

Endocrine therapy

- Not specified


- See Disease Characteristics

- No prior radiotherapy to the head and neck region

- No concurrent brachytherapy


- See Disease Characteristics


- 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

Page last updated: August 23, 2015

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