A Phase II Study of Parotid-gland Sparing IMRT in Patients With Midline Tumour of the Head and Neck

NCT ID: NCT02149602

Last Updated: 2014-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2014-01-31

Brief Summary

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This study is a phase II trial designed to test the feasibility of delivering IMRT to head and neck cancer patients with tumours arising in the midline (oropharynx and hypopharynx), and to assess possible improvement in reducing the incidence of xerostomia with bilateral superficial lobe parotid sparing IMRT.

Detailed Description

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Conditions

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Oropharyngeal Squamous Cell Cancer Hypopharyngeal Squamous Cell Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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oropharyngeal and hypopharyngeal HNSCC

Intensity Modulated Radiotherapy HPV positive and HPV negative

Intensity modulated radiotherapy

Intervention Type RADIATION

Bilateral superficial lobe parotid sparing intensity modulated radiotherapy

Interventions

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Intensity modulated radiotherapy

Bilateral superficial lobe parotid sparing intensity modulated radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed locally advanced HNSCC arising from the oropharynx or hypopharynx with high risk of bilateral parapharyngeal space involvement

Exclusion Criteria

* Patients \<18 years old or with a previous malignancy other than non-melanomatous skin cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher M Nutting, FRCR

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Head and Neck Unit, Royal Marsden Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CCR 2588

Identifier Type: -

Identifier Source: org_study_id

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