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Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer

Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00888823
Enrollment
13
Registered
2009-04-28
Start date
2010-03-31
Completion date
2014-06-30
Last updated
2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Fractionated stereotactic radiotherapy, Medically inoperable, Image-guided radiotherapy

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.

Detailed description

OBJECTIVES: Primary Objectives * To determine the efficacy of hypofractionated, image guided radiotherapy in treating patients with lung tumours, with the primary outcome being local control at one year. * To determine the toxicity of high dose, small field,hypofractionated radiotherapy to the lung, based on the RTOG and CTCAE scales.

Interventions

RADIATIONStereotactic Radiotherapy

Stereotactic Radiotherapy

Sponsors

Cross Cancer Institute
CollaboratorOTHER
AHS Cancer Control Alberta
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Local ControlOne Year

Secondary

MeasureTime frame
ToxicityOne Year
Quality of LifeOne Year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026