Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed Not specified Other ICR-PARSPORT EU-20304, ISRCTN48243537, MREC-03679, NCT00081029

Objectives

Primary

1. 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

1. Compare the degree of xerostomia by quantitative measurements of stimulated and unstimulated salivary flow in patients treated with these regimens.
2. Compare quality of life in patients treated with these regimens.
3. Compare local and regional tumor control, time to tumor progression, and overall survival of patients treated with these regimens.
4. Compare acute and late side effects of these regimens in these patients.

Entry 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

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

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

Expected Enrollment

A total of 84 patients (42 per treatment arm) will be accrued for this study.

Outcomes

Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year

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

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

Trial Contact Information

Trial Lead Organizations

Royal Marsden - London

Chris Nutting, Protocol chair		Ph: 44-20-7808-2586 Email: Chris.Nutting@rmh.nthames.nhs.uk

Registry Information
Official Title		A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer
Trial Start Date		2004-01-01
Trial Completion Date		2013-01-31 (estimated)
Registered in ClinicalTrials.gov		NCT00081029
Date Submitted to PDQ		2004-02-23
Information Last Verified		2008-03-30

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