Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer

February 18, 2016 updated by: AHS Cancer Control Alberta

A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

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:

  • 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

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-year overall survival
Time Frame: 2011
2011

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 2011
2011
Patterns of Failure
Time Frame: 2011
2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer 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

June 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 21, 2009

First Posted (ESTIMATE)

May 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24762

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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