Skip to main content
OpenTrials
Completed

NCT Number: NCT02149602

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oropharyngeal Squamous Cell Cancer Hypopharyngeal Squamous Cell Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Head and Neck Unit, Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensity modulated radiotherapy

Radiation

Bilateral superficial lobe parotid sparing intensity modulated radiotherapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: PARSPORT-II

Important dates

Study start
2005
Primary completion
2011
Study completion
2014
First posted
May 29, 2014
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.