NCT01011842

Brief Summary

To determine if a new optical system that can track a patient's movement during treatment can be used to measure motion and allow for motion adjustments in order to decrease the amount of healthy tissue that receives radiation without limiting our ability to cure cancers using radiation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

November 9, 2009

Last Update Submit

April 5, 2019

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • We are measuring how much a patient moves during treatment.

    This information will be available immediately have the patient is treated.

Study Arms (1)

radiation therapy arm

EXPERIMENTAL
Procedure: RadiotherapyProcedure: Align RT

Interventions

RadiotherapyPROCEDURE

Standard of care

Also known as: Radiation therapy, radiation oncology
radiation therapy arm
Align RTPROCEDURE

Standard of care

Also known as: Image-Guided Radiation Therapy
radiation therapy arm

Eligibility Criteria

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

You may qualify if:

  • Patients with HNC undergoing radiation therapy at Stanford University
  • Age \>= 18 years old
  • Radiation course \>= 4 weeks duration
  • Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Factors such as claustrophobia inhibiting use of thermoplastic mask immobilization device.
  • Patients who are pregnant or nursing, which preclude them from undergoing active radiation treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

RadiotherapyRadiationRadiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Phenomena

Study Officials

  • Quynh-Thu Le

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 11, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

November 1, 2011

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)