Parotid-sparing IMRT for Nasopharyngeal Cancer

Nasopharyngeal Cancers Clinical Trial

Official title:

Phase II Study of Parotid Sparing IMRT for Nasopharyngeal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149641
• Other study ID #: CCR2608
• Status: Completed
• Phase: N/A
• First received: May 26, 2014
• Last updated: May 26, 2014
• Start date: February 2006
• Est. completion date: April 2012

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 CCR and Local and National Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

Description:

The purpose of this study was to determine the feasibility in delivering induction chemotherapy and concomitant chemotherapy with IMRT in the treatment of locally advanced nasopharyngeal cancers and to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• nasopharyngeal cancers

Exclusion Criteria:

• Patients <16 years old or with a previous malignancy other than non-melanomatous skin cancer were excluded

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intensity Modulated Radiotherapy With Chemotherapy
• Nasopharyngeal Cancers
• Nasopharyngeal Neoplasms

Intervention

Radiation:
• Intensity modulated radiotherapy with chemotherapy

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	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 incidence of =G2 xerostomia at 1 year using the subjective component LENTSOMA		12 months	No
Secondary	Acute radiation toxicities		0-3 months	No
Secondary	Late radiation toxicities		3-24 months	No
Secondary	loco-regional disease-free survival (LRDFS), progression-free survival (PFS) and overall survival (OS)		2 years	No
Secondary	chemotherapy compliance and toxicities		0-12 weeks	No