Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers
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ClinicalTrials.gov Identifier: NCT02068313
Recruitment Status : Unknown
Verified February 2014 by Royal Marsden NHS Foundation Trust. Recruitment status was: Recruiting
Phase II and III studies have demonstrated IMRT to be safe and standard practice for head and neck cancers treated with radiotherapy. This study will be an extension to an earlier, in-house, trial to allow continued recording of toxicities and outcomes in patients receiving IMRT for head and neck cancers. This study will allow us to examine radiobiological modelling for normal tissue complication probability and in particular, determining the dose threshold for parotid glands. Our primary objective is to assess the potential effectiveness of intensity-modulated radiotherapy (IMRT) in reducing xerostomia in head and neck cancer patients and determining threshold dose for whole parotid gland and superficial lobes of parotid glands
To assess the potential effectiveness of intensity-modulated radiotherapy (IMRT) in reducing xerostomia in head and neck cancer patients and determining threshold dose for whole parotid gland and superficial lobes of parotid glands [ Time Frame: 5 years ]
Secondary Outcome Measures :
To quantify acute and late toxicities of IMRT to provide data for radiobiological modelling (eg xerostomia, mucositis and dysphagia) [ Time Frame: 5 years ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with histologically confirmed squamous cell cancer or undifferentiated cancer of nasopharynx, oropharynx, larynx and hypopharynx and squamous cell carcinoma unknown primary referred for primary or postoperative radiotherapy to the primary site and bilateral neck irradiation requiring IMRT
Histologically confirmed squamous cell cancer or undifferentiated cancer of nasopharynx, oropharynx, larynx and hypopharynx and squamous cell carcinoma unknown primary.
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
Previous radiotherapy to the parotid gland/s
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