NCT00351962

Brief Summary

Medically inoperable lung cancer or metastatic lung tumours will be treated with fractionated stereotactic radiation using a schedule of 1) 12 Gy x 4 treatments or 2) 6 Gy x 10 treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

July 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2014

Completed
Last Updated

September 21, 2017

Status Verified

July 1, 2013

Enrollment Period

7.8 years

First QC Date

July 11, 2006

Last Update Submit

September 20, 2017

Conditions

Lung NeoplasmsLung Cancer

Keywords

lung neoplasmsmetastatic lung cancerstereotactic radiation

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicity as defined by CTCAE V3 grade 4 or 5.

    Each schedule will be evaluated according to the occurrence of DLTs observed.

    At the completion of accrual, an analysis with respect to acute toxicity will be performed after all patients have been followed a minimum of 90 days from the start of RT.

Study Arms (2)

Schedule I (10 fractions)

EXPERIMENTAL

Subjects will receive a total of 10 stereotactic radiation treatments, given over 3 weeks.

Procedure: Fractionated Stereotactic Radiotherapy

Schedule II (4 fractions)

EXPERIMENTAL

Subjects will receive a total of 4 stereotactic radiation treatments, given over 2 weeks.

Procedure: Fractionated Stereotactic Radiotherapy

Interventions

Fractionated Stereotactic RadiotherapyPROCEDURE
Schedule I (10 fractions)Schedule II (4 fractions)

Eligibility Criteria

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

You may qualify if:

  • non-small cell lung cancer less than 6cm; no mediastinal or distant metastases
  • Open to Alberta,Canada Residents

You may not qualify if:

  • tumour size greater than 6cm; inadequate pulmonary function(ie. FEV1 less than 0.8 L), Karnofsky performance status less than 70, multiple co-morbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Harold P Lau, MD

    Tom Baker Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

September 1, 2006

Primary Completion

July 1, 2014

Study Completion

July 2, 2014

Last Updated

September 21, 2017

Record last verified: 2013-07

Locations

CA(1)