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Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

Primary Purpose

Lung Neoplasm, Small Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Hypofractionated Chest Radiotherapy
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasm focused on measuring Small cell lung cancer, radiotherapy dose escalation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • limited stage small cell lung cancer
  • adequate pulmonary function test (FEV1 >1.0 L, DLCO >50%)
  • signed study consent
  • age at least 18 years
  • Karnofsky performance status as least 70%
  • eligible to receive standard concurrent small cell cancer chemotherapy

Exclusion Criteria:

  • extensive stage disease
  • mixed non small cell and small cell histology
  • inadequate pulmonary function tests
  • not eligible for concurrent chemotherapy
  • subtotal or total tumor resection
  • previous chest/neck radiotherapy
  • prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years
  • pregnant
  • prior chemotherapy for another malignancy
  • patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias

Sites / Locations

  • Cross Cancer Institute

Outcomes

Primary Outcome Measures

2-year overall survival

Secondary Outcome Measures

Quality of life
Patterns of Failure

Full Information

First Posted
May 20, 2009
Last Updated
February 18, 2016
Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00907569
Brief Title
Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer
Official Title
A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (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
It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.
Detailed Description
The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. Strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving higher than standard daily doses) facilitates both of these goals. In this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with LS-SCLC.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Chest Radiotherapy
Intervention Description
Hypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks.
Primary Outcome Measure Information:
Title
2-year overall survival
Time Frame
2011
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
2011
Title
Patterns of Failure
Time Frame
2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: limited stage small cell lung cancer adequate pulmonary function test (FEV1 >1.0 L, DLCO >50%) signed study consent age at least 18 years Karnofsky performance status as least 70% eligible to receive standard concurrent small cell cancer chemotherapy Exclusion Criteria: extensive stage disease mixed non small cell and small cell histology inadequate pulmonary function tests not eligible for concurrent chemotherapy subtotal or total tumor resection previous chest/neck radiotherapy prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years pregnant prior chemotherapy for another malignancy patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

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Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

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