Phase II trialCancer Trials Ireland (ICORG) 06-34: A multi-centre clinical trial using three-dimensional conformal radiation therapy to reduce the toxicity of palliative radiation for lung cancer
Section snippets
Purpose
The primary purpose of this Cancer Trials Ireland (ICORG) 06-34 clinical trial was to demonstrate that using technically advanced 3-DCRT for the palliative treatment of lung cancer patients would result in equivalent degrees of symptom relief and a reduction in the primary endpoint of oesophagitis.
Trial design
The trial was an ICH-GCP compliant non-blinded, non-randomised single arm clinical trial with a toxicity related primary objective. Participating patients were treated using 3-DCRT with one of three external beam radiation therapy (EBRT) fractionation schedules, 17 Gy in 2 fractions, 20 Gy in 5 fractions or 39 Gy in 13 fractions. The appropriate treatment schedule was selected by the radiation oncologist based on individual patient factors such as performance status and life-expectancy. The
Results
From July 2010 to November 2013, three Irish institutions accrued 43 eligible patients. All available data were included and analysed. Two patients died before their first treatment, three patients died during treatment, 1 patient was too ill to complete treatment, 1 patient was scanned with his arms down thus a conformal plan was not possible, and there was no toxicity data for one patient who became confused. Five patients died before the 1-month follow-up. Consequently, data from 30 patients
Discussion
Oesophagitis and dysphagia are the two commonly reported oesophageal toxicities in palliative lung studies. Whilst these both result in altered swallowing, they are defined separately as disorders characterised by inflammation of the oesophageal wall usually resulting in pain and difficulty in swallowing, respectively. Sunstrøm et al., in a Norwegian randomised trial demonstrated that the mean time for onset of dysphagia after radiation is approximately two weeks and tends to be resolved by
References (25)
- et al.
Palliative radiation for stage 3 non-small cell lung cancer – a prospective study of two moderately high dose regimens
Lung Cancer
(1995) - et al.
Immediate side effects of large fraction radiotherapy
Clin Oncol (R Coll Radiol)
(1997) - et al.
Symptom control and quality of life in People with Lung Cancer: a randomised trial of two palliative radiotherapy fractionation schedules
Clin Oncol (R Coll Radiol)
(2005) - et al.
Positron emission tomography and computed tomographic imaging (PET/CT) for dose planning purposes of thoracic radiation with curative intent in lung cancer patients: a systematic review and meta-analysis
Radiother Oncol
(2017) - et al.
Multiple training interventions significantly improve reproducibility of PET/CT-based lung cancer radiotherapy target volume delineation using an IAEA protocol
Radiother Oncol
(2016) - et al.
Dose escalation of CHART in non-small cell lung cancer: is three-dimensional conformal radiation therapy really necessary?
Int J Radiat Oncol Bio Phys
(1999) - et al.
EORTC Quality of Life Group. The development of the EORTC QLQ-C15 PAL: a shortened questionnaire for cancer patients in palliative care
Eur J Cancer
(2006) - et al.
Three-dimensional conformal radiation therapy may improve the therapeutic ratio of high dose radiation therapy for lung cancer
Int J Radiat Oncol Biol Phys
(1993) - et al.
Virtual simulation in palliative lung radiation therapy
Clin Oncol
(2004) - et al.
The international Atomic Energy Agency (IAEA) randomized trial of palliative treatment of incurable locally advanced non small cell lung cancer (NSCLC) using radiotherapy (RT) and chemotherapy (CHT) in limited resource setting
Radiother Oncol
(2015)
Cancer statistics
CA Cancer J Clin
Cited by (12)
EGCG, a green tea polyphenol, as one more weapon in the arsenal to fight radiation esophagitis?
2019, Radiotherapy and OncologyA shift from simple to sophisticated: using intensity-modulated radiation therapy in conventional nonstereotactic palliative radiotherapy
2023, Current Opinion in Supportive and Palliative Care