Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, Brachytherapy, Radiotherapy, Palliation, Dysphagia Read More

Inclusion Criteria:

• Endoscopic and biopsy-proven carcinoma of the esophagus, either Adenocarcinoma or Squamous cell carcinoma;
• Lesions of the thoracic oesophagus and the abdominal oesophagus but not involving the cardia of the stomach. (The oesophagus extends from the cricopharyngeus muscle at the level of the cricoid cartilage to the GEJ junction. The most proximate cervical oesophagus extends approximately 2-3 cm distal to the cricopharyngeus muscle approximately 18 cm from the incisors, and is excluded from this study; however the remaining oesophagus is included in this study, including the last 1-2 cm of the oesophagus which is intra-abdominal and up to the GEJ.);
• Dysphagia immediately prior to the first HDR ILBT session (based on a 4-question summary score of 4-15 (i.e. less than a score of 16) using four of the questions from the EORTC QLQ OES-18 measure;
• Able to insert the intra-esophageal applicator (Dilatation is allowed to open up the tumor/lumen to facilitate insertion, and this does not preclude eligibility. Any oesophageal stent must be removed prior to brachytherapy because metal stents may inappropriately 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 as all will have at least dysphagia from disease at baseline; patients with KPS <40 are not eligible for this study);
• Eligible for radiotherapy (e.g. any pacemaker is not within 2.5 cm of the outside of the 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, and should be considered for patients with complete obstruction or where there has been substantial 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 neck or lung primary cancers (regardless of whether those malignancies could be managed with curative intent);
• Failure to complete all baseline assessments required for the study, including patient-elicited scores for symptoms and QOL;
• Pregnant or lactating patients.