Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer
Phase 1
Completed
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT00888823
- Lead Sponsor
- AHS Cancer Control Alberta
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Local Control One Year
- Secondary Outcome Measures
Name Time Method Toxicity One Year Quality of Life One Year
Trial Locations
- Locations (2)
Tom Baker Cancer Center
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada