Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers
NCT ID: NCT02068313
Last Updated: 2014-02-21
Study Results
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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UNKNOWN
300 participants
OBSERVATIONAL
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single cohort
Toxicity and outcome measures of IMRT
Interventions
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Toxicity and outcome measures of IMRT
Eligibility Criteria
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Inclusion Criteria
* TNM Stage: T1-4, N0-3 M0
* Patients requiring primary or postoperative radiotherapy to the primary site and bilateral neck irradiation requiring IMRT
* Parotid sparing IMRT feasible (parotids clear of malignant disease)
* WHO Performance status 0-1 (Karnofsky \>80)
* Aged 18 or older
* Induction chemotherapy and concomitant platinum based chemotherapy is permitted
* Concomitant cetuximab is permitted where platinum chemotherapy is contraindicated
* All patients must be suitable to attend regular follow-up and salivary flow measurements and be available for long term follow up.
* All patients must be able to complete self-assessed quality of life questionnaire
* Be able to provide written informed consent
Exclusion Criteria
* Pre-existing salivary gland pathology interfering with saliva production
* Previous or concurrent illness which in the investigator's opinion which will interfere with either completion of therapy or follow up
* Brachytherapy is not allowed as part of the treatment
* Presence of lymphadenopathy adjacent to or involving both parotid glands making whole parotid sparing or superficial parotid sparing impossible
* Prophylactic use of amifostine or pilocarpine is not allowed
18 Years
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Christopher Nutting, PhD, MD, FRCR, MRCP, MB BS
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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The Royal Marsden Hospital
Sutton, Surrey, United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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CCR 3301
Identifier Type: -
Identifier Source: org_study_id
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