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

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ClinicalTrials.gov Identifier: NCT02149602
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
Oropharyngeal Squamous Cell Cancer Hypopharyngeal Squamous Cell Cancer Radiation: Intensity modulated radiotherapy

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase II Study of Parotid-gland Sparing Intensity-modulated Radiotherapy in Patients With Midline Tumour of the Head and Neck
Study Start Date : July 2005
Primary Completion Date : November 2011
Study Completion Date : January 2014

Group/Cohort Intervention/treatment
oropharyngeal and hypopharyngeal HNSCC
Intensity Modulated Radiotherapy HPV positive and HPV negative
Radiation: Intensity modulated radiotherapy
Bilateral superficial lobe parotid sparing intensity modulated radiotherapy

Primary Outcome Measures :
  1. The proportion of patients reporting grade 2 or more xerostomia using subjective measure on the LENTSOMA late toxicity scoring scale one year after treatment. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Acute radiation toxicity [ Time Frame: 0-3 months ]
  2. Late radiation toxicity [ Time Frame: 3-24 months ]
  3. Survival outcomes for entire cohort and according to HPV status where available : Local control, Loco regional control, Loco-regional progression-free survival (LRPFS), Disease free survival, Overall survival. [ Time Frame: 24 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Midline pharyngeal squamous cell cancers (excluding nasopharyngeal cancers)

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

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): NCT02149602

United Kingdom
Head and Neck Unit, Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Principal Investigator: Christopher M Nutting, FRCR Royal Marsden NHS Foundation Trust

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02149602     History of Changes
Other Study ID Numbers: CCR 2588
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by Royal Marsden NHS Foundation Trust:
involvement of bilateral parapharyngeal spaces

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site