Role of Radiotherapy Following Oesophageal Stenting in Cancer
NCT ID: NCT01179074
Last Updated: 2010-08-11
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
NA
84 participants
INTERVENTIONAL
2007-04-30
2009-03-31
Brief Summary
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Detailed Description
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STUDY AIM: To compare dysphagia relief in patients treated with oesophageal stenting and external beam radiotherapy (EBRT), versus oesophageal stenting alone and to assess overall survival, treatment related complications, and quality of life in the two groups.
PATIENTS AND METHODS: Patients with inoperable oesophageal cancer with high grade dysphagia to be randomised to receive oesophageal stenting alone (Group I), versus a combination of stenting followed by EBRT (Group II). Dysphagia relief, treatment related complications, overall survival, and quality of life to be assessed in the two groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Oesophageal stent alone
Patients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents
oesophageal stenting with self expandable metal stent
oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
Oesophageal stent followed by EBRT
Patients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks)
oesophageal stenting with self expandable metal stent
oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
Oesophageal stent followed by external beam radiotherapy
30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group
Interventions
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oesophageal stenting with self expandable metal stent
oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
Oesophageal stent followed by external beam radiotherapy
30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic disease, and co-morbid conditions precluding major surgical procedure (such as severe cardiopulmonary, hepatic and renal diseases) with grade 3 and 4 dysphagia, were included in the trial.
Exclusion Criteria
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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Department of G.I.Surgery, All India Institute of Medical Sciences, New Delhi-110029
Principal Investigators
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Tushar K Chattopadhyay, MS
Role: STUDY_DIRECTOR
Head, Dept. G.I Surgery, All India Institute of Medical Sciences, New Delhi
Locations
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Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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References
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Schmid EU, Alberts AS, Greeff F, Terblanche AP, Schoeman L, Burger W, Shiels RA, Friediger D, Van der Hoven A, Falkson G. The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial. Radiother Oncol. 1993 Jul;28(1):27-30. doi: 10.1016/0167-8140(93)90181-7.
Other Identifiers
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SEMSRT-1
Identifier Type: -
Identifier Source: org_study_id
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