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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Tracking Information | ||||
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First Submitted Date ICMJE | January 21, 2010 | |||
First Posted Date ICMJE | January 22, 2010 | |||
Last Update Posted Date | April 2, 2012 | |||
Study Start Date ICMJE | December 2009 | |||
Estimated Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall survival and Median Survival [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Quality of life [ECOG performance status],Dysphagia grade [ Stooler stand],Change of the oesophageal cancer [ RECIST standard],Restenosis degree[esophagus visualization] • Pathologic change of the cancer, • Successful rate of stent placement, [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | a Multicentric Randomized Controlled Trial of Self-Expandable Esophageal Radiation Stent | |||
Official Title ICMJE | Self-Expandable Esophageal Radiation Stent:a Multicentric Randomized Controlled Trial in Patients With Advanced Esophageal Cancer | |||
Brief Summary | Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. Brachytherapy and esophageal self-expanding stent insertion have longer benefit. Stent insertion provides fastest improvement of dysphagia.However, recurrence of the neoplastic stricture remains a challenge after stent placement, complications in later setting occur and require further endoscopic treatment. Brachytherapy has slower onset of benefit but has fewer complications and longer benefit.To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. And a small-sample and unicentric prior clinical trial in the authors' institute certificated the novel esophageal stent can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life markedly. This current multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work compared with a conventional covered stent in patients with malignant dysphagia caused by advanced esophageal cancer. | |||
Detailed Description | PURPOSE Rationale: Placing a stent in the esophagus may relieve the dysphagia caused by inoperable esophageal cancer rapidly and improve the quality of life . But recurrence of the neoplastic stricture remains a challenge after solitary stent placement. Brachytherapy is an option for palliation of the symptoms due to the esophageal strictures,however,it can not relieve the dysphagia rapidly. So a novel esophageal stent loaded with 125I seeds combines the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy. Purpose: A small-sample and unicentric clinical trial in the authors' institute had certificated that a novel esophageal stent loaded with 125I seeds for intraluminal brachytherapy can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life . This multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work compared with a conventional covered stent in patients with malignant dysphagia caused by advanced esophageal cancer. OUTLINE: This is a multicentric, randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
Condition :Esophageal Cancer Intervention (Procedure): Esophageal stent placement,dysphagia scores,complications of therapy,survival time of therapy Phase :Ⅲ DISEASE AND PATIENT CHARACTERISTICS: Criteria Inclusion Criteria:
Exclusion Criteria:
Exit or Termination Criteria: Patient Exit :
Termination:
Case exfoliation : Definition:any participant who has signed and entered the trial do not insist to the end.The reasons may be:
Exfoliation handle:
Case rejection:
RANDOMIZATION Trial design:
Case diffusion Be sent to one of two arms according to the random number randomized formed by the SAS statistics software. Radiation dose estimation: After balloon dilation ( the special balloon producted for esophageal dilation by Nanjing MicroInvasive Medical,Nanjing,China) in participants[the balloon diameter is 16mm in superior segment of esophagus and 18mm in the midpiece and inferior segment of esophagus],CT scan of the esophagus with the balloon in is performed.Then the images will be send to the Treatment Planning System(TPS, Nanjing MicroInvasive Medical,Nanjing,China),and the bulk of the oesophageal cancer will be calculated according to the CT three-dimensional reconstruction images.At last,the radiation dose will be estimated(with radioactivity 0.7mCi according to the preclinical study). Choice of stent and seeds fixation: The esophageal irradiation stent combined a self-expandable covered esophageal stent(MTN;Nanjing MicroInvasive Medical,Nanjing,China) loaded (or not loaded) with 125I radiative seeds(CIAE-6711;Chinese Atomic Energy Science Institution,Beijing,China) are chose.The diameter varies from 16 to 18mm(16mm in superior segment of esophagus and 18mm in the midpiece and inferior segment of esophagus), the length is the length of disease with additional 20mm. The seeds (number is decided according to the radiation dose estimated in advance)are fixed around the stent,covering the superior and inferior border of the cancer (the distance of seeds varies from 10mm to 15mm and the distance of seeds and inlet/outlet less than10mm). Post-operation Care Participants lie on the back with waist raised after stent insertion, common treatments include hemostasis, infection prevention, mucous membrane of esophagus and stomach protection.No cold diet,except eating fluid slowly. Follow-up Calling or visiting the patients every month after test insertion. Objectives: [Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ] Primary:
Secondary
Safety
Statistical analysis: All primal date should be stored completely and precisely and submitted to the special date administrator in time by the Internet.Before entering the date into the special database by two people independent, all submitted data must be reviewed, verified to ensure the accuracy, currency(according to the primal date). Statistical analysis software of SAS 9.0 is adapted. Test of two-sided, if P ≤0.05,there are significant difference. Mean, standard deviation(SD),median, maximum and minimum value are used to describe the measurement data of two groups;the rank sum test is used to valuate the relief of dysphagia;log-rank test is used to compare the survival curves of two groups which have been drawn with the Kaplan-meier method.At last the median survivals will be obtained and compared by t test and rank sum test . Constituent ratio is used to describe the numeration data of two groups; u test is used to valuate the difference of survival rates;and the reasons of restenosis are analysed with Fisher's exact test or chi-square(X2) test. The balance-analyses of fundament data(population data and others): t test or chi-square(X2) test is chose. Esophageal Cancer PURPOSE Rationale: Placing a stent in the esophagus may relieve the dysphagia caused by inoperable esophageal cancer rapidly and improve the quality of life . But recurrence of the neoplastic stricture remains a challenge after solitary stent placement. Brachytherapy is an option for palliation of the symptoms due to the esophageal strictures,however,it can not relieve the dysphagia rapidly. So a novel esophageal stent loaded with 125I seeds combines the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy. Purpose: A small-sample and unicentric clinical trial in the authors' institute had certificated that a novel esophageal stent loaded with 125I seeds for intraluminal brachytherapy can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life . This multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work com |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Esophageal Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
180 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | Not Provided | |||
Estimated Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01054274 | |||
Other Study ID Numbers ICMJE | 320924197612177170 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Gao-Jun Teng, Southeast University, China | |||
Original Responsible Party | Gao-Jun Teng,MD/Dean,Medical School,Southeast University, Zhongda Hospital,Southeast University | |||
Current Study Sponsor ICMJE | Southeast University, China | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Southeast University, China | |||
Verification Date | December 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |