PARSPORT-II: A Phase II Study of Parotid-gland Sparing IMRT in Patients With Midline Tumour of the Head and Neck
Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT02149602
Collaborator
(none)
120
1
102
1.2
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
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
:
Jul 1, 2005
Actual Primary Completion Date
:
Nov 1, 2011
Actual Study Completion Date
:
Jan 1, 2014
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Head and Neck Unit, Royal Marsden Hospital | London | United Kingdom | SW3 6JJ |
Sponsors and Collaborators
- Royal Marsden NHS Foundation Trust
Investigators
- Principal Investigator: Christopher M Nutting, FRCR, Royal Marsden NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02149602
Other Study ID Numbers:
- CCR 2588
First Posted:
May 29, 2014
Last Update Posted:
May 29, 2014
Last Verified:
May 1, 2014
Keywords provided by Royal Marsden NHS Foundation Trust
Additional relevant MeSH terms: