A Clinical Trial Using 3-Dimensional Conformal Radiation Therapy to Reduce the Toxicity of Palliative Radiation for Lung Cancer
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
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Occurrence of esophagitis grade 3 or higher according to CTCAE Version 4.02
John Gerard Armstrong, MD, MB, MRCPI
Saint Luke's Hospital
Ireland: Research Ethics Committee