Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer. ICORG 06-34

March 30, 2016 updated by: Cancer Trials Ireland

A Clinical Trial Using 3-Dimensional Conformal Radiation Therapy to Reduce the Toxicity of Palliative Radiation for Lung Cancer

RATIONALE: 3-dimensional conformal radiation therapy may lessen side effects caused by palliative radiation therapy and improve the quality of life of patients with lung cancer.

PURPOSE: This clinical trial is studying how well 3-dimensional conformal radiation therapy works in reducing the side effects of palliative radiation in patients with lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of this study is to demonstrate that using technically sophisticated 3-dimensional conformal radiation therapy for the palliative treatment of lung cancer patients will result in equivalent degrees of symptom relief and a reduction in the primary endpoint of oesophagitis.

Single arm therapeutic clinical study.

RT Treatment Regimens:

17 Gy/2 fractions or 20Gy/5 fractions or 39Gy/13 fractions

Primary Endpoint:

-The occurrence of Grade 3 or higher oesophagitis in the interval between start and 1-month post completion of treatment as determined by CTCAE Version 4.02

Patients will be assessed pre treatment, during treatment, 2 weeks post completion of treatment, one month post completion of treatment, three months post completion of treatment, and three monthly thereafter

-All patients who complete treatment (and whose on-treatment toxicity is documented) will be evaluable.

Secondary Endpoint:

  • Quality of Life Assessment. All patients will be required to complete the EORTC QLQ-C15-PAL (Version 1) and the Lung Specific Module (LC 13)
  • The occurrence of other AEs

Safety Endpoint:

-Radio-induced oesophagitis, acute and long term, using the CTCAE Version 4.02.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

  • Ireland
      • Dublin, Ireland, 6
        • St Luke's Radiation Oncology Network (SLRON)
      • Galway, Ireland
        • Galway University Hospital

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:

  • Age > 18 years
  • Karnofsky Performance Status of > or equal to 40%
  • Patients with locally advanced or metastatic small cell or non-small cell lung cancer
  • The presence of intra-thoracic symptoms requiring palliative treatment
  • WBI (if required) is permitted
  • The patient's condition must permit waiting for the 3-dimensional design process to be implemented. This will be at the discretion of the Consultant Physician
  • Patients presenting with pleural effusions - provided the pleural effusion does not prevent the reasonably accurate delineation of the target volume
  • Intra-thoracic disease requiring palliation must be clearly evident on a diagnostic CT scan
  • Life expectancy of at least 3 months (assessed by clinician)
  • Provision of written informed consent in line with ICH-GCP guidelines

Exclusion Criteria:

-In the opinion of the Investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
A clinical trial using 3-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer
Other: questionnaire administration
Procedure: quality-of-life assessment
Radiation: 3-dimensional conformal radiation therapy
Radiation: whole-brain radiation therapy
Radiation: palliative radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02
Time Frame: 2015
2015
Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13)
Time Frame: 2015
2015

Secondary Outcome Measures

Outcome Measure
Time Frame
Local intra-thoracic symptoms
Time Frame: 2015
2015

Collaborators and Investigators

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

Sponsor

Cancer Trials Ireland

Investigators

  • Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI, Saint Luke's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-34 ICORG
  • ICORG-06-34
  • EU-21056

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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