NCT02149602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

6.3 years

First QC Date

May 26, 2014

Last Update Submit

May 26, 2014

Conditions

Oropharyngeal Squamous Cell CancerHypopharyngeal Squamous Cell Cancer

Keywords

involvement of bilateral parapharyngeal spaces

Outcome Measures

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.

    12 months

Secondary Outcomes (3)

  • Acute radiation toxicity

    0-3 months

  • Late radiation toxicity

    3-24 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

Study Arms (1)

oropharyngeal and hypopharyngeal HNSCC

Intensity Modulated Radiotherapy HPV positive and HPV negative

Radiation: Intensity modulated radiotherapy

Interventions

Intensity modulated radiotherapyRADIATION

Bilateral superficial lobe parotid sparing intensity modulated radiotherapy

oropharyngeal and hypopharyngeal HNSCC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Midline pharyngeal squamous cell cancers (excluding nasopharyngeal cancers)

You may qualify if:

  • histologically confirmed locally advanced HNSCC arising from the oropharynx or hypopharynx with high risk of bilateral parapharyngeal space involvement

You may not qualify if:

  • Patients \<18 years old or with a previous malignancy other than non-melanomatous skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Head and Neck Unit, Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Interventions

Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Christopher M Nutting, FRCR

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

July 1, 2005

Primary Completion

November 1, 2011

Study Completion

January 1, 2014

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

GB(1)