a Multicentric Randomized Controlled Trial of Self-Expandable Esophageal Radiation Stent
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ClinicalTrials.gov Identifier: NCT01054274 |
Recruitment Status : Unknown
Verified December 2009 by Gao-Jun Teng, Southeast University, China.
Recruitment status was: Recruiting
First Posted : January 22, 2010
Last Update Posted : April 2, 2012
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Condition or disease | Intervention/treatment | Phase |
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Esophageal Cancer | Device: novel stent Device: conventional covered stent | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Self-Expandable Esophageal Radiation Stent:a Multicentric Randomized Controlled Trial in Patients With Advanced Esophageal Cancer |
Study Start Date : | December 2009 |
Estimated Primary Completion Date : | December 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: novel stent
Patients undergo placement of a novel esophageal stent loaded with 125I seeds on day 1.
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Device: novel stent
Patients undergo placement of a novel esophageal stent loaded with 125I seeds on day 1.
Other Name: self-expandable esophageal radiation stent |
Experimental: conventional covered stent
Patients undergo placement of a conventional covered stent on day 1.
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Device: conventional covered stent
Patients undergo placement of a conventional covered stent on day 1.
Other Name: conventional stent |
- Overall survival and Median Survival [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ]
- Quality of life [ECOG performance status],Dysphagia grade [STOOLER stand],Change of the oesophageal cancer [ RECIST standard],Restenosis degree[esophagus visualization] [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ]
- Pathologic change of the cancer [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ]
- Successful rate of stent placement [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ]
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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Endoscopically and histologically confirmed cancer of esophagus
- Progressive dysphagia caused by esophageal cancer, and the dysphagia grade of level Ⅲ or level Ⅳ[STOOLER stand]
- In barium meal of esophagus, severe stricture of the cancer make the barium difficult to pass through and the superior normal esophagus broaden
- The bulk and shape of the oesophageal cancer displayed by CT three-dimensional reconstruction
- Patients with clear consciousness,Cooperation,ECOG performance status of 0,1 and 3
- Informed consent: authorization and signature
Exclusion Criteria:
- Poor general status,ECOG performance status of 4,
- Dysphagia not caused by esophageal cancer,
- Noncooperation or no authorization and signature.
- The superior border of cancer higher than the seventh cervical vertebrae
- Ulcerative esophageal carcinoma
- Esophageal fistulas,
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WBC less than 3000/mm3
- Severe hepatic inadequacy or renal inadequacy,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054274
Contact: Gao-Jun Teng, MD | +86 25 83272121 | gjteng@vip.sina.com |
China, Jiangsu | |
Zhongda Hospital, Southeast University | Recruiting |
Nanjing, Jiangsu, China, 210009 |
Principal Investigator: | Gao-Jun Teng, MD | Medical School,Southeast University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Gao-Jun Teng, Director, Southeast University, China |
ClinicalTrials.gov Identifier: | NCT01054274 |
Other Study ID Numbers: |
320924197612177170 |
First Posted: | January 22, 2010 Key Record Dates |
Last Update Posted: | April 2, 2012 |
Last Verified: | December 2009 |
esophageal cancer dysphagia stent brachytherapy |
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |