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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

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What is being tested

management of therapy complications

+ radiation therapy
Procedure
Radiation
Who is being recruted

Head and Neck Cancer

+ Radiation Toxicity
+ Xerostomia
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2004

Summary

Principal SponsorRoyal Marsden NHS Foundation Trust
Last updated: March 23, 2011
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitleA Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer 
Principal SponsorRoyal Marsden NHS Foundation Trust
Last updated: March 23, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
84 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Head and Neck Cancer
Radiation Toxicity
Xerostomia
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 9 locations
Suspended
Addenbrooke's HospitalCambridge, United KingdomSee the location
Suspended
Princess Royal Hospital at Hull and East Yorkshire NHS TrustHull, United Kingdom
Suspended
Ipswich HospitalIpswich, United Kingdom
Suspended
Barts and the London School of MedicineLondon, United Kingdom

Suspended9 Study Centers