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 Clinical Trial

Official title:

A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00081029
• Other study ID #: CDR0000358803
• Secondary ID: ICR-PARSPORTEU-2
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 7, 2004
• Last updated: March 22, 2011
• Start date: January 2004

Study information

• Verified date: March 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiation Injuries
• Radiation Toxicity
• Xerostomia

Intervention

Procedure:
• management of therapy complications

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Princess Royal Hospital at Hull and East Yorkshire NHS Trust	Hull	England
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Barts and the London School of Medicine	London	England
United Kingdom	Royal Marsden - London	London	England
United Kingdom	University College Hospital - London	London	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	University Hospital of North Staffordshire	Stoke-On-Trent	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Clark CH, Hansen VN, Chantler H, Edwards C, James HV, Webster G, Miles EA, Guerrero Urbano MT, Bhide SA, Bidmead AM, Nutting CM; PARSPORT Trial Management Group. Dosimetry audit for a multi-centre IMRT head and neck trial. Radiother Oncol. 2009 Oct;93(1): — View Citation

Clark CH, Miles EA, Urbano MT, Bhide SA, Bidmead AM, Harrington KJ, Nutting CM; UK PARSPORT Trial Management Group collaborators. Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre P — View Citation

Nutting CM, Morden JP, Harrington KJ, Urbano TG, Bhide SA, Clark C, Miles EA, Miah AB, Newbold K, Tanay M, Adab F, Jefferies SJ, Scrase C, Yap BK, A'Hern RP, Sydenham MA, Emson M, Hall E; PARSPORT trial management group. Parotid-sparing intensity modulate — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients suffering xerostomia = grade 2 by LENT/SOMA late toxicity scale at 1 year			Yes
Secondary	Degree of xerostomia by salivary flow at 1 year			No
Secondary	Xerosomia-related quality of life by Modified Xerostomia questionnaire at 1 year			No
Secondary	Quality of Life by EORTC QLQ C30 v.3.0 and QLQ-H&N35 questionnaires at 1 year			No
Secondary	Local and regional tumor control by a quantitative description of sites of relapse at 1 year			No
Secondary	Time to tumor progression at 1 year			No
Secondary	Overall survival at 1 year			No
Secondary	Acuteside effects of radiotherapy by NCI CTCAE scale v. 3.0 at 1 year			Yes
Secondary	Late side effects of radiotherapy by NCI CTCAE scale v3.0, LENT SOMA and RTOG at 1 year			Yes