Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia
NCT ID: NCT00665197
Last Updated: 2011-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2007-02-28
2011-02-28
Brief Summary
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Detailed Description
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A cost-effectiveness analysis is not required because the main contrast is between 5 and 10 fractions of EBRT, where 5 fractions are less expensive than 10 fractions. This protocol follows the recommendations of CONSORT for the reporting of non-inferiority and equivalence trials. The active control is 30 Gy in 10 fractions, and the new therapy is 20 Gy in 5 fractions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Protracted Course Radiotherapy
High Dose Rate brachytherapy 8.0 Gy x 2
External beam radiotherapy 30 Gy in 10 fractions of 3.0 Gy
Protracted Course Radiotherapy
External Beam Radiation 30 Gy in 10 fractions
Short Course Radiotherapy
High Dose Rate brachytherapy 8.0 Gy x 2
External beam radiotherapy 20 Gy in 5 fractions of 4.0 Gy
Short Course Radiotherapy
External Beam Radiation 20 Gy in 5 fractions
Interventions
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Protracted Course Radiotherapy
External Beam Radiation 30 Gy in 10 fractions
Short Course Radiotherapy
External Beam Radiation 20 Gy in 5 fractions
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients suitable for curative treatment with either surgery or chemo-radiation;
* Tracheo-esophageal fistula, or deep mucosal ulceration;
* Perforation or massive esophageal bleeding ;
* 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.
18 Years
81 Years
ALL
No
Sponsors
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International Atomic Energy Agency
OTHER_GOV
Responsible Party
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Principal Investigators
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Eduardo Rosenblatt, MD
Role: STUDY_CHAIR
International Atomic Energy Agency
Locations
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Credit Valley Hospital Statistical Centre
Credit Valley, Ontario, Canada
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
University of Zagreb Clinical Hospital
Zagreb, City of Zagreb, Croatia
Tata Memorial Hospital
Mumbai, Parel, India
Institute of Nuclear Medicine and Oncology
Lahore, Punjab Province, Pakistan
University of the Witwatersrand Department of Radiat. Oncology
Johannesburg, Parktown, South Africa
Mahidol University Faculty of Medicine Siriraj Hospital
Bangkok, Siriraj, Thailand
Countries
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References
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Sur RK, Donde B, Levin VC, Mannell A. Fractionated high dose rate intraluminal brachytherapy in palliation of advanced esophageal cancer. Int J Radiat Oncol Biol Phys. 1998 Jan 15;40(2):447-53. doi: 10.1016/s0360-3016(97)00710-4.
Sur RK, Levin CV, Donde B, Sharma V, Miszczyk L, Nag S. Prospective randomized trial of HDR brachytherapy as a sole modality in palliation of advanced esophageal carcinoma--an International Atomic Energy Agency study. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):127-33. doi: 10.1016/s0360-3016(02)02702-5.
Gaspar LE, Nag S, Herskovic A, Mantravadi R, Speiser B. American Brachytherapy Society (ABS) consensus guidelines for brachytherapy of esophageal cancer. Clinical Research Committee, American Brachytherapy Society, Philadelphia, PA. Int J Radiat Oncol Biol Phys. 1997 Apr 1;38(1):127-32. doi: 10.1016/s0360-3016(97)00231-9.
Kumar MU, Swamy K, Supe SS, Anantha N. Influence of intraluminal brachytherapy dose on complications in the treatment of esophageal cancer. Int J Radiat Oncol Biol Phys. 1993 Dec 1;27(5):1069-72. doi: 10.1016/0360-3016(93)90525-z.
Related Links
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IAEA website
Other Identifiers
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E3.30.27
Identifier Type: -
Identifier Source: org_study_id