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

This study has been completed.
Information provided by (Responsible Party):
Cancer Trials Ireland Identifier:
First received: August 5, 2010
Last updated: March 30, 2016
Last verified: March 2016

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.

Condition Intervention
Lung Cancer
Other: questionnaire administration
Procedure: quality-of-life assessment
Radiation: 3-dimensional conformal radiation therapy
Radiation: palliative radiation therapy
Radiation: whole-brain radiation therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Clinical Trial Using 3-Dimensional Conformal Radiation Therapy to Reduce the Toxicity of Palliative Radiation for Lung Cancer

Resource links provided by NLM:

Further study details as provided by Cancer Trials Ireland:

Primary Outcome Measures:
  • Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02 [ Time Frame: 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 ]

Secondary Outcome Measures:
  • Local intra-thoracic symptoms [ Time Frame: 2015 ]

Estimated Enrollment: 40
Study Start Date: June 2010
Study Completion Date: March 2016
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: palliative radiation therapy Radiation: whole-brain radiation therapy

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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Please refer to this study by its identifier: NCT01176487

St Luke's Radiation Oncology Network (SLRON)
Dublin, Ireland, 6
Galway University Hospital
Galway, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI Saint Luke's Hospital
  More Information

Responsible Party: Cancer Trials Ireland Identifier: NCT01176487     History of Changes
Other Study ID Numbers: 06-34 ICORG
Study First Received: August 5, 2010
Last Updated: March 30, 2016

Keywords provided by Cancer Trials Ireland:
recurrent non-small cell lung cancer
recurrent small cell lung cancer
extensive stage small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on May 25, 2017