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

Oropharyngeal Squamous Cell Cancer Clinical Trial

— PARSPORT-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149602
• Other study ID #: CCR 2588
• Status: Completed
• Phase: N/A
• First received: May 26, 2014
• Last updated: May 26, 2014
• Start date: July 2005
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Royal Marsden Committee of Clinical Research and Local and National Research and Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2014
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Hypopharyngeal Squamous Cell Cancer
• Neoplasms, Squamous Cell
• Oropharyngeal Squamous Cell Cancer

Intervention

Radiation:
• Intensity modulated radiotherapy
Bilateral superficial lobe parotid sparing intensity modulated radiotherapy

Locations

Country	Name	City	State
United Kingdom	Head and Neck Unit, Royal Marsden Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Acute radiation toxicity		0-3 months	No
Secondary	Late radiation toxicity		3-24 months	No
Secondary	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	No