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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02149602
Acronym
PARSPORT-II
Enrollment
120
Registered
2014-05-29
Start date
2005-07-31
Completion date
2014-01-31
Last updated
2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopharyngeal Squamous Cell Cancer, Oropharyngeal Squamous Cell Cancer

Keywords

involvement of bilateral parapharyngeal spaces

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.

Interventions

RADIATIONIntensity modulated radiotherapy

Bilateral superficial lobe parotid sparing intensity modulated radiotherapy

Sponsors

Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The proportion of patients reporting grade 2 or more xerostomia using subjective measure on the LENTSOMA late toxicity scoring scale one year after treatment.12 months

Secondary

MeasureTime frame
Acute radiation toxicity0-3 months
Late radiation toxicity3-24 months
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.24 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026