Back to resultsPilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Adaptive Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small cell lung cancer, Adaptive radiotherapy, Thoracic radiotherapy
Eligibility Criteria
Inclusion Criteria:
- patients with histologically or cytologically proven newly diagnosed small cell lung cancer
- chest-confined disease (including bulky intrathoracic disease)
- adequate pulmonary function tests (FEV-1>1.0 L, DLCO>50%)
- patients of childbearing potential must practice adequate contraception
- Age > or = 18 years
- Karnofsky performance status > or = 70
- eligible for concurrent chemoradiotherapy
Exclusion Criteria:
- patients who have undergone complete or subtotal tumour resection
- evidence of non-small cell histology
- prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
- prior RT to the thorax or neck
- compromised lung function with inadequate pulmonary function tests (FEV-1<1.0,DLCO<50%)
- pregnant women
Sites / Locations
- Cross Cancer Institute
Outcomes
Primary Outcome Measures
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray
Secondary Outcome Measures
Local control and patterns of failure
Local control and patterns of failure
Survival
Full Information
NCT ID
NCT01426841
First Posted
April 15, 2011
Last Updated
October 1, 2014
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT01426841
Brief Title
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
Official Title
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small cell lung cancer, Adaptive radiotherapy, Thoracic radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Adaptive Radiation
Intervention Description
Thoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment
Primary Outcome Measure Information:
Title
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach
Description
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray
Time Frame
12-24 months
Secondary Outcome Measure Information:
Title
Local control and patterns of failure
Description
Local control and patterns of failure
Time Frame
12-24 months
Title
Survival
Time Frame
12-24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with histologically or cytologically proven newly diagnosed small cell lung cancer
chest-confined disease (including bulky intrathoracic disease)
adequate pulmonary function tests (FEV-1>1.0 L, DLCO>50%)
patients of childbearing potential must practice adequate contraception
Age > or = 18 years
Karnofsky performance status > or = 70
eligible for concurrent chemoradiotherapy
Exclusion Criteria:
patients who have undergone complete or subtotal tumour resection
evidence of non-small cell histology
prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
prior RT to the thorax or neck
compromised lung function with inadequate pulmonary function tests (FEV-1<1.0,DLCO<50%)
pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Yee, MD, FRCPC
Organizational Affiliation
Cross Cancer Institute, Alberta Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer
We'll reach out to this number within 24 hrs