- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01647334
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
February 17, 2015 updated by: David Palma, Lawson Health Research Institute
This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment.
The study will use adaptive radiotherapy to achieve these goals.
Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie.
weight loss or tumor shrinkage).
This may allow for dose escalation, while limiting the side effects.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program of the Lawson Health Research Institute
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or older
- Willing to provide informed consent
- ECOG performance status 0-2
- Histologically confirmed non-small cell lung carcinoma
- Locally advanced stage IIIA or IIIB lung carcinoma according to AJCC 7th edition
- Expected lung V20 of 35-60%, as determined at the time of 4D-CT simulation
- Assessment by medical oncologist and radiation oncologist, with adequate hepatic and renal function for administration of cisplatin-based doublet chemotherapy, at the discretion of the medical oncologist
Exclusion Criteria:
- Serious medical comorbidities or other contraindications to radiotherapy or chemotherapy
- Prior history of lung cancer within 5 years
- Prior thoracic radiation at any time
- Metastatic disease
- in some select cases, patients with a solitary metastasis (i.e. brain metastasis) may receive radical chemoradiotherapy after resection/ablation of their metastatic lesion, as standard practice. In such cases, the patient may be enrolled onto this study at the discretion of the local principle investigator once the metastasis has been treated.
- inability to attend full course of radiotherapy of follow-up visits
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Shrinking Target Adaptive Radiotherapy
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor reduction
Time Frame: 2.5 years (end of treatment)
|
2.5 years (end of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2.5 years
|
2.5 years
|
Rate of tumor shrinkage
Time Frame: 2.5 years (end of treatment)
|
2.5 years (end of treatment)
|
Change in lung dose
Time Frame: 2.5 years (end of treatment)
|
2.5 years (end of treatment)
|
Delivered doses
Time Frame: 2.5 years (end of treatment)
|
2.5 years (end of treatment)
|
Radiation pneumonitis rates
Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months (semi-annually)
|
6 months, 12 months, 18 months, 24 months, 30 months (semi-annually)
|
Local control
Time Frame: 2.5 years (end of treatment)
|
2.5 years (end of treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Palma, MD, PhD, London Regional Cancer Program of the Lawson Health Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
July 19, 2012
First Submitted That Met QC Criteria
July 19, 2012
First Posted (Estimate)
July 23, 2012
Study Record Updates
Last Update Posted (Estimate)
February 19, 2015
Last Update Submitted That Met QC Criteria
February 17, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lung-START
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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