NCT00888823

Brief Summary

A new type of treatment called stereotactic radiotherapy has recently been developed in hopes of improving the success of the treatment and improving the convenience to patients, while reducing the side effects. This study is developing stereotactic radiotherapy as a state-of-the-art treatment for lung cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2010

Typical duration for phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

3.9 years

First QC Date

April 27, 2009

Last Update Submit

March 14, 2016

Conditions

Non-small Cell Lung Cancer

Keywords

Fractionated stereotactic radiotherapyMedically inoperableImage-guided radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Local Control

    One Year

Secondary Outcomes (2)

  • Toxicity

    One Year

  • Quality of Life

    One Year

Interventions

Stereotactic RadiotherapyRADIATION

Stereotactic Radiotherapy

Eligibility Criteria

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

You may qualify if:

  • T1-T3N0 non-small cell lung cancer (maximum dimensions of 5cm, T3 by chestwall involvement only)
  • Medically inoperable due to co-morbid conditions or patient preference for radiation
  • adequate pulmonary function to withstand radical treatment (ie. FEV1 greater than 40% of predicted), as assessed by consulting radiation oncologist
  • age greater than or equal to 18, and Karnofsky performance status greater than of equal to 70

You may not qualify if:

  • Presence of mediastinal metastases or distant metastases
  • Life expectancy less than 1 year due to other co-morbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tom Baker Cancer Center

Calgary, Alberta, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

March 1, 2010

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

CA(2)