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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01176487
First received: August 5, 2010
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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 ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02 [ Time Frame: 2015 ] [ Designated as safety issue: Yes ]
  • Quality of life as assessed using the EORTC QLQ-C15-PAL (Version 1) questionnaire and the Lung Specific Module (LC 13) [ Time Frame: 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local intra-thoracic symptoms [ Time Frame: 2015 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176487

Locations
Ireland
St Luke's Radiation Oncology Network (SLRON)
Dublin, Ireland, 6
Galway University Hospital
Galway, Ireland
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: John Gerard Armstrong, MD, MB, MRCPI Saint Luke's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT01176487     History of Changes
Other Study ID Numbers: CDR0000682636, ICORG-06-34, EU-21056
Study First Received: August 5, 2010
Last Updated: January 20, 2014
Health Authority: Ireland: Research Ethics Committee

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014