Phase II trial
Cancer 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

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Abstract

Title

Cancer 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. NCT01176487.

Background & purpose

Trials of radiation therapy for the palliation of intra-thoracic symptoms from locally advanced non-small cell lung cancer (NSCLC) have concentrated on optimising fractionation and dose schedules. In these trials, the rates of oesophagitis induced by this “palliative” therapy have been unacceptably high. In contrast, this non-randomised, single-arm trial was designed to assess if more technically advanced treatment techniques would result in equivalent symptom relief and reduce the side-effect of symptomatic oesophagitis.

Materials & methods

Thirty-five evaluable patients with symptomatic locally advanced or metastatic NSCLC were treated using a three-dimensional conformal technique (3-DCRT) and standardised dose regimens of 39 Gy in 13 fractions, 20 Gy in 5 fractions or 17 Gy in 2 fractions. Treatment plans sought to minimise oesophageal dose. Oesophagitis was recorded during treatment, at two weeks, one month and three months following radiation therapy and 3–6 monthly thereafter. Mean dose to the irradiated oesophagus was calculated for all treatment plans.

Results

Five patients (14%) had experienced grade 2 oesophagitis or dysphagia or both during treatment and 2 other patients had these side effects at the 2-week follow-up. At follow-up of one month after therapy, there was no grade two or higher oesophagitis or dysphagia reported. 22 patients were eligible for assessment of late toxicity. Five of these patients reported oesophagitis or dysphagia (one had grade 3 dysphagia, two had grade 2 oesophagitis, one of whom also had grade 2 dysphagia). Quality of Life (QoL) data at baseline and at 1-month follow up were available for 20 patients. At 1-month post radiation therapy, these patients had slightly less trouble taking a short walk, less shortness of breath, did not feel as weak, had better appetite and generally had a better overall quality of life than they did at baseline. They did report being slightly more tired.

Conclusions

This trial is the first of its kind showing that 3-DCRT provides patients with lower rates of oesophageal toxicity whilst yielding acceptable rates of symptom control. (Sponsored by Cancer Trials Ireland (ICORG) Study number 06-34, the Friends of St. Luke’s and the St. Luke’s Institute of Cancer Research.)

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

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