Back to resultsHypofractionated Radiotherapy for Small Cell Lung Cancer
Primary Purpose
Lung Neoplasm, Small Cell Carcinoma
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
hypofractionated external beam
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasm focused on measuring small cell lung cancer, radiotherapy dose escalation
Eligibility Criteria
Inclusion Criteria:
- patients with histologically or cytologically proven newly diagnosed small cell lung cancer
- confirmation from the treating radiation oncologist that the patient has limited stage disease (i.e. disease that can be encompassed by radiotherapy portals without exposing patient to excessive risk of radiation lung injury)
- adequate pulmonary function tests (FEV-1 >1.0, DLCO >50%)
- patients of childbearing potential must practice adequate contraception
- age greater than 18 years
- Karnofsky performance status greater than 70
- adequate hematologic, hepatic and renal function: Hb>100g/L, WBC > 4.0x109/L, neutrophils > 1.0x109/L, platelets > 100,000x109/L, calculated GFR based on Cockcroft-Gault formula of >60mL/min (NOTE: for cisplatin, GFR must be above 60ml/min; if less than 60ml/min the patient can not receive cisplatin but could be considered for carboplatin)
- patients must sign a study specific informed consent form
Exclusion Criteria:
- patient who have undergone complete or subtotal tumour resection
- evidence of non-small cell histology
- pericardial or pleural effusion on radiologic investigations regardless of cytology
- patients cannot be treated with 3DCRT with adherence to the dose volume constraints
- prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
- prior radiotherapy to the thorax or neck
- prior chemotherapy
- patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmias
- compromised lung function with inadequate pulmonary function tests (FEV-1<1.0, DLCO <50%)
- pregnancy (patients with childbearing potential must practice appropriate contraception)
- patients who have not had the pre-treatment evaluations outlined in the protocol
Sites / Locations
- Cross Cancer Institute
Outcomes
Primary Outcome Measures
Rates of acute grade 3 or higher radiotherapy toxicities
Secondary Outcome Measures
Overall survival and disease free survival, patient related quality of life
Full Information
NCT ID
NCT00469222
First Posted
May 2, 2007
Last Updated
February 24, 2016
Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT00469222
Brief Title
Hypofractionated Radiotherapy for Small Cell Lung Cancer
Official Title
Phase I Dose Escalation Trial of Hypofractionated Limited-field External Beam Thoracic Radiotherapy for Limited Stage Small Cell Carcinoma of the Lung
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Current treatments for limited stage small cell lung cancer have poor cure rates. The addition of chest radiation to chemotherapy improves cure rates, but these cancers still come back in the chest 30-50% of the time. Two factors which can improve control and cure rates for this cancer are increasing the chest radiation dose and minimizing the overall time it takes to complete radiation treatments. One method to achieve both of these goals is to give more radiation each day. This study is meant to study how tolerable and effective it would be to increase the intensity of chest radiation for small cell lung cancer patients by increasing the daily radiation dose. We aim to find the highest dose of chest radiotherapy that can be safely given with chemotherapy using this strategy. Patients in this trial will be monitored before, during and after their radiation and chemotherapy treatments for treatment side-effects, how effective treatments are at controlling their cancer and quality of life changes. Results from this trial will help to define more effective radiotherapy doses which are tolerable for this type of lung cancer and the quality of life changes patients experience when they undergo these treatments.
Detailed Description
Local control and overall survival rates associated with the standard chemotherapy and radiotherapy given for limited stage small cell lung cancer are poor and emerging evidence from several studies suggests that intensifying the radiotherapy dose given may further improve patient outcomes, but at the cost of increased radiotherapy side effects. This proposal aims to study a novel method of intensifying chest radiotherapy dose via increasing the daily radiotherapy dose which is directed at regions of visible disease only. This strategy allows for delivery of increased radiation doses without prolonging overall treatment time and allowing potential regrowth of cancer cells. We aim to determine the maximum radiation dose which can be safely given with chemotherapy for limited stage small cell lung cancer and study the effects this type of radiation regimen with chemotherapy has on patient side effects and quality of life. Results from this trial will contribute to the development of the ideal radiotherapy regimen for limited stage small cell lung cancer. Our results will add to the literature studying the effects dose-intense radiation strategies for lung cancer have on patient quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm, Small Cell Carcinoma
Keywords
small cell lung cancer, radiotherapy dose escalation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
hypofractionated external beam
Primary Outcome Measure Information:
Title
Rates of acute grade 3 or higher radiotherapy toxicities
Secondary Outcome Measure Information:
Title
Overall survival and disease free survival, patient related quality of life
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
confirmation from the treating radiation oncologist that the patient has limited stage disease (i.e. disease that can be encompassed by radiotherapy portals without exposing patient to excessive risk of radiation lung injury)
adequate pulmonary function tests (FEV-1 >1.0, DLCO >50%)
patients of childbearing potential must practice adequate contraception
age greater than 18 years
Karnofsky performance status greater than 70
adequate hematologic, hepatic and renal function: Hb>100g/L, WBC > 4.0x109/L, neutrophils > 1.0x109/L, platelets > 100,000x109/L, calculated GFR based on Cockcroft-Gault formula of >60mL/min (NOTE: for cisplatin, GFR must be above 60ml/min; if less than 60ml/min the patient can not receive cisplatin but could be considered for carboplatin)
patients must sign a study specific informed consent form
Exclusion Criteria:
patient who have undergone complete or subtotal tumour resection
evidence of non-small cell histology
pericardial or pleural effusion on radiologic investigations regardless of cytology
patients cannot be treated with 3DCRT with adherence to the dose volume constraints
prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
prior radiotherapy to the thorax or neck
prior chemotherapy
patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmias
compromised lung function with inadequate pulmonary function tests (FEV-1<1.0, DLCO <50%)
pregnancy (patients with childbearing potential must practice appropriate contraception)
patients who have not had the pre-treatment evaluations outlined in the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Yee, MD
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
Hypofractionated Radiotherapy for Small Cell Lung Cancer
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