A previous IAEA study on 232 patients has demonstrated the efficacy of fractionated high dose rate brachytherapy (HDR BT) in the palliative management of dysphagia. A pilot study has shown no additional morbidity on 30 patients treated with HDR BT plus external beam teletherapy (EBRT) against that seen in 30 patients treated by HDR BT alone. A recent Agency study demonstrated an advantage in palliation with the addition of EBRT in a randomised study of 219 patients. The present coordinated research project (CRP) will test if giving the EBRT in one week gives equivalent palliation of symptoms as giving it in two weeks. The CRP is open to radiotherapy institutions where HDR BT using microsource Ir-192 and teletherapy (cobalt and/or linac) and simulation (or CT planning) are available. The centres will need to agree to provide in excess of 20 patients per year with advanced Mo or M+ oesophageal squamous carcinoma to the study. Only raw data will be required; all analysis will be performed at a selected Technical Contract centre
To determine if a shorter regime of external beam radiotherapy (EBRT), using higher daily doses, combined with intraluminal high dose rate brachytherapy (HDR ILBT) gives equal palliation, in terms of dysphagia and/or survival, as a a more protracted course of EBRT, using lower daily doses, combined with equal HDR ILBT, in the management of advanced oesophagus cancer.
[1] To determine if a shorter regime of external beam radiotherapy (20 Gy in 5 fractions over 1 week) combined with HDR brachytheapy gives equal palliation in terms of dysphagia and associated symptoms than a more protracted regimen of 30 Gy in 10 fractions.
[2] To determine the comparative survival rates of both regimens.
[3] To determine the comparative toxicity and quality of life scores of both regimens.
This is another important trial of the IAEA in oesophagus cancer, with regards to palliative management. Oesophageal cancer is more common in some developing countries as compared with Western countries, and so is an important resource commitment in such countries, both for institutions and for patients, many of whom pay out-of-pocket for treatments.
Prior trials of the IAEA established 2 ILBT brachytherapy treatments as effective palliation, as compared with more fractions, and established 2 x ILBT + 30 Gy in 10 fractions External Beam as better than 2 x ILBT alone. This new trial may establish that 2 x ILBT + 20 Gy in 5 fractions External Beam is no worse than 2 x ILBT + 30 Gy in 10 fractions External Beam, in terms of toxicities and outcomes (e.g. symptom relief), or that the shorter approach is superior to the longer, more resource-intense approach. In addition, it will decide whether EBRT adds anything to ILBT in the M1 context or sub-group, given their short survival experiences, during which ILBT may be sufficient for local control and symptom management. Therefore, patients and centres will be benefited by this trial being completed and reported in a timely manner.
The use of a short fractionation schedule will represent convenience for the patients and resource-sparing for centres and countries.