Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer

February 24, 2016 updated by: AHS Cancer Control Alberta
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
radiotherapy toxicities
Time Frame: 1-2 years after study treatment
1-2 years after study treatment
patient quality of life
Time Frame: 1-2 years after study treatment
1-2 years after study treatment
overall survival
Time Frame: 1-2 years after study treatment
1-2 years after study treatment

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

February 1, 2008

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (ESTIMATE)

March 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LU-23929/23929

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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