Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
AHS Cancer Control Alberta
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00888823
First received: April 27, 2009
Last updated: March 14, 2016
Last verified: March 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Radiation: Stereotactic Radiotherapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicentre, Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC) |
Resource links provided by NLM:
Further study details as provided by AHS Cancer Control Alberta:
Primary Outcome Measures:
- Local Control [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Toxicity [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: One Year ] [ Designated as safety issue: No ]
| Enrollment: | 13 |
| Study Start Date: | March 2010 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Radiation: Stereotactic Radiotherapy
Stereotactic Radiotherapy
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888823
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888823
Locations
| Canada, Alberta | |
| Tom Baker Cancer Center | |
| Calgary, Alberta, Canada | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada | |
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
More Information
| Responsible Party: | AHS Cancer Control Alberta |
| ClinicalTrials.gov Identifier: | NCT00888823 History of Changes |
| Other Study ID Numbers: | 24541/ethics24761 |
| Study First Received: | April 27, 2009 |
| Last Updated: | March 14, 2016 |
| Health Authority: | Canada: Health Canada |
Keywords provided by AHS Cancer Control Alberta:
|
Fractionated stereotactic radiotherapy Medically inoperable Image-guided radiotherapy |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
ClinicalTrials.gov processed this record on September 23, 2016