Status:
COMPLETED
Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia
Lead Sponsor:
International Atomic Energy Agency
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-81 years
Phase:
PHASE3
Brief Summary
Hypothesis: In the management of advanced oesophageal cancer, to determine if a shorter regime of external beam radiotherapy (using higher daily doses, and combined with intraluminal high dose rate br...
Detailed Description
This is a prospective, pragmatic and multi-centre clinical trial, without blinding or masking to the randomly assigned treatment. Patient registration and randomization are centralized. There are two ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00665197
Start Date
February 1 2007
End Date
February 1 2011
Last Update
October 13 2011
Active Locations (7)
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1
Credit Valley Hospital Statistical Centre
Credit Valley, Ontario, Canada, L5M 2N1
2
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
3
University of Zagreb Clinical Hospital
Zagreb, City of Zagreb, Croatia, 10000
4
Tata Memorial Hospital
Mumbai, Parel, India, 490 012