Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia

Inclusion Criteria:

• Endoscopic and biopsy-proven carcinoma of the esophagus, either Adenocarcinoma orSquamous cell carcinoma;

• Lesions of the thoracic oesophagus and the abdominal oesophagus but not involving thecardia of the stomach. (The oesophagus extends from the cricopharyngeus muscle at thelevel of the cricoid cartilage to the GEJ junction. The most proximate cervicaloesophagus extends approximately 2-3 cm distal to the cricopharyngeus muscleapproximately 18 cm from the incisors, and is excluded from this study; however theremaining oesophagus is included in this study, including the last 1-2 cm of theoesophagus which is intra-abdominal and up to the GEJ.);

• Dysphagia immediately prior to the first HDR ILBT session (based on a 4-questionsummary score of 4-15 (i.e. less than a score of 16) using four of the questions fromthe EORTC QLQ OES-18 measure;

• Able to insert the intra-esophageal applicator (Dilatation is allowed to open up thetumor/lumen to facilitate insertion, and this does not preclude eligibility. Anyoesophageal stent must be removed prior to brachytherapy because metal stents mayinappropriately increase the dose of radiation to the esophageal wall by approximately 10%.]);

• Karnofsky is between 40 and 90, inclusive and at baseline (no patient can be 100 asall will have at least dysphagia from disease at baseline; patients with KPS <40 arenot eligible for this study);

• Eligible for radiotherapy (e.g. any pacemaker is not within 2.5 cm of the outside ofthe field edge for the EBRT component of therapy);

• Signed informed consent.

Exclusion Criteria:

• Age less than 18;

• Patients suitable for curative treatment with either surgery or chemo-radiation;

• Tracheo-esophageal fistula, or deep mucosal ulceration;

• Perforation or massive esophageal bleeding ;

• Previous treatment (e.g. chemotherapy, radiation therapy, laser therapy or surgery)for esophageal cancer (gastrostomy or PEG does not constitute exclusion criteria, andshould be considered for patients with complete obstruction or where there has beensubstantial loss in body weight prior to diagnosis);

• Stents in situ (i.e. not removed prior to the first HDR ILBT);

• Previous thoracic radiation therapy for any cause, either EBRT or ILBT;

• Evidence of other uncontrolled malignancies, or evidence of synchronous head and neckor lung primary cancers (regardless of whether those malignancies could be managedwith curative intent);

• Failure to complete all baseline assessments required for the study, includingpatient-elicited scores for symptoms and QOL;

• Pregnant or lactating patients.