Palliative 3-Dimensional Conformal Radiation Therapy in Reducing Radiation Side Effects in Patients With Lung Cancer. ICORG 06-34
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.
Other: questionnaire administration
Procedure: quality-of-life assessment
Radiation: 3-dimensional conformal radiation therapy
Radiation: palliative radiation therapy
Radiation: whole-brain radiation therapy
|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|
- 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 ]
- Local intra-thoracic symptoms [ Time Frame: 2015 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||March 2016|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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|
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
-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.
- 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
-Radio-induced oesophagitis, acute and long term, using the CTCAE Version 4.02.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176487
|St Luke's Radiation Oncology Network (SLRON)|
|Dublin, Ireland, 6|
|Galway University Hospital|
|Principal Investigator:||John Gerard Armstrong, MD, MB, MRCPI||Saint Luke's Hospital|