NCT02149641

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.2 years 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

5.2 years

First QC Date

May 26, 2014

Last Update Submit

May 26, 2014

Conditions

Nasopharyngeal CancersIntensity Modulated Radiotherapy With Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • the incidence of ≥G2 xerostomia at 1 year using the subjective component LENTSOMA

    12 months

Secondary Outcomes (4)

  • Acute radiation toxicities

    0-3 months

  • Late radiation toxicities

    3-24 months

  • loco-regional disease-free survival (LRDFS), progression-free survival (PFS) and overall survival (OS)

    2 years

  • chemotherapy compliance and toxicities

    0-12 weeks

Study Arms (1)

Nasopharyngeal cancers

Intensitiy modulated radiotherapy with chemotherapy

Radiation: Intensity modulated radiotherapy with chemotherapy

Interventions

Intensity modulated radiotherapy with chemotherapyRADIATION
Nasopharyngeal cancers

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

nasopharyngeal cancers

You may qualify if:

  • nasopharyngeal cancers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Radiotherapy, Intensity-ModulatedDrug Therapy

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

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

February 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2012

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

GB(1)