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

Phase 3

• Conditions: Radiation Toxicity; Head and Neck Cancer; Xerostomia

• Registration Number: NCT00081029
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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 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.

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-04-07
• Study First Submitted QC: 2004-04-07
• Study First Posted: 2004-04-08
• Status Verified: 2008-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23
• Primary Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival at 1 year
Time to tumor progression 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
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

Trial Locations

Locations (9)

University Hospital of North Staffordshire; 🇬🇧 Stoke-On-Trent, 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

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

Princess Royal Hospital at Hull and East Yorkshire NHS Trust; 🇬🇧 Hull, England, United Kingdom

Cancer Research Centre at Weston Park Hospital; 🇬🇧 Sheffield, England, United Kingdom

University College Hospital - London; 🇬🇧 London, England, United Kingdom

Christie Hospital; 🇬🇧 Manchester, England, United Kingdom