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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
AHS Cancer Control Alberta
About
Eligibility
Locations
Outcomes
Full info

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

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

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

First Posted
March 24, 2008
Last Updated
February 24, 2016
Sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
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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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