NCT00168116

Brief Summary

The purpose of this study is to compare the side effects of radiation treatment and surgery versus radiation alone, where no surgery is done to move the salivary gland and place it under the chin region where it can be shielded from radiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_2 head-and-neck-cancer

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

July 1, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 24, 2016

Status Verified

October 1, 2011

Enrollment Period

8.8 years

First QC Date

September 12, 2005

Last Update Submit

February 23, 2016

Conditions

Head and Neck Cancer

Keywords

nasopharynxxerostomiaprevention

Outcome Measures

Primary Outcomes (1)

  • Quality of life

Secondary Outcomes (7)

  • Treatment interruptions

  • Incidence of percutaneous endoscopic gastronomy (PEG)

  • Incidence of oral candidiasis

  • Overall survival

  • Disease free survival

  • +2 more secondary outcomes

Interventions

radiation treatment and surgeryPROCEDURE
radiation alonePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a histological diagnosis of squamous cell carcinoma
  • Patients with unilateral or no neck involvement of the nasopharynx
  • The submandibular transfer will be done on the uninvolved side of the neck.
  • Karnofsky score greater than or equal to 70
  • Expected survival greater than one year
  • A signed informed consent

You may not qualify if:

  • Bilateral neck nodes involvement. Involvement of level 1 lymph nodes on the side of the proposed procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsXerostomia

Interventions

RadiotherapySurgical Procedures, OperativeRadiation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Phenomena

Study Officials

  • Naresh Jha, MBBA

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

July 1, 2000

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

February 24, 2016

Record last verified: 2011-10

Locations

CA(1)