Parotid-sparing IMRT for Nasopharyngeal Cancer | NCT02149641

Studies
Parotid-sparing IMRT for Nasopharyngeal Cancer

NCT02149641

Sponsor

Royal Marsden NHS Foundation Trust

Status

Completed

Last Update Posted

May 29, 2014Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Nasopharyngeal Cancers
Intensity Modulated Radiotherapy With Chemotherapy

Interventions

Intensity modulated radiotherapy with chemotherapy

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2012Actual

First Submitted Date

May 26, 2014

First Submission Date that Met QC Criteria

May 26, 2014

First Posted Date

May 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2014

Last Update Posted Date

May 29, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nasopharyngeal cancers		Intensitiy modulated radiotherapy with chemotherapy	Radiation: Intensity modulated radiotherapy with chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intensity modulated radiotherapy with chemotherapy	Radiation		Nasopharyngeal cancers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of ≥G2 xerostomia at 1 year using the subjective component LENTSOMA		12 months

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

nasopharyngeal cancers

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

nasopharyngeal cancers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher M Nutting, FRCR	Royal Marsden NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Royal Marsden NHS Foundation Trust		London		SW3 6JJ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009303	Nasopharyngeal Neoplasms

Ancestor Terms

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050397	Radiotherapy, Intensity-Modulated
D004358	Drug Therapy

Ancestor Terms

ID	Term
D020266	Radiotherapy, Conformal
D011881	Radiotherapy, Computer-Assisted
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided