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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
First Posted : February 21, 2014
Last Update Posted : February 21, 2014
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
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

Condition or disease Intervention/treatment
Head and Neck Cancer Radiation: Toxicity and outcome measures of IMRT

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase II Study of Whole or Partial Parotid Sparing Intensity Modulated Radiotherapy in Patients With Head and Neck Cancers
Study Start Date : March 2010
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Single cohort Radiation: Toxicity and outcome measures of IMRT



Primary Outcome Measures :
  1. 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 :
  1. To quantify acute and late toxicities of IMRT to provide data for radiobiological modelling (eg xerostomia, mucositis and dysphagia) [ Time Frame: 5 years ]
  2. Overall survival [ Time Frame: 5 years ]
  3. Disease free survival [ Time Frame: 5 years ]
  4. Loco-regional control [ Time Frame: 5 years ]
  5. General and specific QoL [ Time Frame: 5 years ]
  6. Xerostomia related QoL [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068313


Contacts
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Contact: Rachel Starkings, MSc 0207 811 8311 Rachel.Starkings@rmh.nhs.uk

Locations
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United Kingdom
The Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
The Royal Marsden Hospital Recruiting
London, United Kingdom, sw3 6jj
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Principal Investigator: Christopher Nutting, PhD, MD, FRCR, MRCP, MB BS Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02068313     History of Changes
Other Study ID Numbers: CCR 3301
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: February 21, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms