Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
Primary Purpose
Extensive Stage Small Cel Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
thoracic radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Extensive Stage Small Cel Lung Cancer focused on measuring small cell lung cancer, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Histologic or cytologic confirmation of small cell lung cancer
- extensive stage disease
- adequate pulmonary function tests (FEV-1>1.0, DLCO>50%)
- patients of childbearing potential must practice adequate contraception
- age ≧ 18 years
- Karnofsky performance status ≧ 70
- documented objective response to initial chemotherapy
- signed study-specific informed consent form
Exclusion Criteria:
- complete or subtotal tumor resection
- non-small cell histology
- prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years
- prior chest or neck RT
- inadequate pulmonary function tests (FEV-1<1.0 OR DLCO<50%)
- pregnant
Sites / Locations
- Cross Cancer Institute
Outcomes
Primary Outcome Measures
local control
Secondary Outcome Measures
radiotherapy toxicities
patient quality of life
overall survival
Full Information
NCT ID
NCT00643396
First Posted
March 24, 2008
Last Updated
February 24, 2016
Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00643396
Brief Title
Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
Official Title
Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
4. Oversight
5. Study Description
Brief Summary
The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's quality of life and in some situation be life-threatening. In this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. By giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Small Cel Lung Cancer
Keywords
small cell lung cancer, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
thoracic radiotherapy
Primary Outcome Measure Information:
Title
local control
Time Frame
we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment
Secondary Outcome Measure Information:
Title
radiotherapy toxicities
Time Frame
1-2 years after study treatment
Title
patient quality of life
Time Frame
1-2 years after study treatment
Title
overall survival
Time Frame
1-2 years after study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic confirmation of small cell lung cancer
extensive stage disease
adequate pulmonary function tests (FEV-1>1.0, DLCO>50%)
patients of childbearing potential must practice adequate contraception
age ≧ 18 years
Karnofsky performance status ≧ 70
documented objective response to initial chemotherapy
signed study-specific informed consent form
Exclusion Criteria:
complete or subtotal tumor resection
non-small cell histology
prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years
prior chest or neck RT
inadequate pulmonary function tests (FEV-1<1.0 OR DLCO<50%)
pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Yee, MD, FRCPC
Organizational Affiliation
AHS Cancer Control Alberta
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
Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
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