- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00826813
Trial Using 125I Embedded Stent in Patients With Advanced Esophageal Cancer
21. januar 2009 opdateret af: Southeast University, China
Phase IV Study of Self-Expandable Esophageal Stent Loaded With 125I Seeds: a Randomized Controlled Multiple Center Trial in Patients With Advanced Esophageal Cancer
More than half of patients with esophageal cancer are inoperable because of late stage cancer or metastasis and they have to undergo palliative treatments.
Dysphagia is the major symptom of patients with inoperable esophageal cancer.
To relieve the dysphagia and improve the quality of life of such patients, stent placement has been widely accepted to be an option for palliation of the symptoms.
However, recurrence of the neoplastic stricture remains a challenge after stent placement.
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 preliminary clinical trial in a single institute has demonstrated better results than the conventional stent.
This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Esophageal cancer ranks 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.
However, recurrence of the neoplastic stricture remains a challenge after stent placement.
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.
The following preliminary clinical study in a single institute has demonstrated longer survival time, better quality of life and less restenosis of the stent than whose with the conventional stent.
This prospective multiple center trial is designed to further demonstrate the clinical outcomes with this irradiation, stent in patients compared to those using a conventional covered stent.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
250
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Jiangsu
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Nanjing, Jiangsu, Kina, 210009
- #87 Dingjiaqiao Road
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histologically confirmed primary cancer of esophagus,
- Must be dysphagia caused by esophageal cancer,
- Without esophageal fistulas,
- Must be an inpatient,
- Life expectancy is over 6 months
Exclusion Criteria:
- Esophageal fistulas,
- Tracheal compression with symptoms,
- WBC <2000/mm3 and Platelet count <50,000/mm3,
- Concurrent therapies after stenting:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: stenting
The conventional esophageal stent or 125I radiation stent is placed in the patients with dysphagia who are enrolled to the study.
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The esophageal stent combined a self-expandable covered esophageal stent and 125I radioactive seeds.
Sheathes were attached to the outer surface of the stent, containing 125I radioactive seeds of CIAE 6711.
The seeds were loaded into the sheathes on the stent immediately before implantation of the stent.
The numbers and dose of the radioactive stent seeds was determined by the treatment plan system based on the size of the individual tumor.
To cover the entire lesion of the tumor by the sheaths containing 125I seeds, at least 2 cm exceeding the tumor margins was required.
The distance between the two sheaths was 15mm.
In the control group, conventional covered esophageal stents were used which provided by the same company as those attached with 125I seeds.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Overall survival
Tidsramme: Death of the patient
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Death of the patient
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Quality of life
Tidsramme: 3, 6, 12 months
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3, 6, 12 months
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Restenosis of the stent
Tidsramme: 3, 6, 12 months
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3, 6, 12 months
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Dysphagia relief
Tidsramme: 3, 6, 12 months
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3, 6, 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Gao-Jun Teng, MD, Ph.D, Zhongda Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Guo JH, Teng GJ, Zhu GY, He SC, Deng G, He J. Self-expandable stent loaded with 125I seeds: feasibility and safety in a rabbit model. Eur J Radiol. 2007 Feb;61(2):356-61. doi: 10.1016/j.ejrad.2006.10.003. Epub 2006 Nov 7.
- Guo JH, Teng GJ, Zhu GY, He SC, Fang W, Deng G, Li GZ. Self-expandable esophageal stent loaded with 125I seeds: initial experience in patients with advanced esophageal cancer. Radiology. 2008 May;247(2):574-81. doi: 10.1148/radiol.2472070999. Epub 2008 Mar 18.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2009
Primær færdiggørelse (Forventet)
1. marts 2010
Studieafslutning (Forventet)
1. marts 2011
Datoer for studieregistrering
Først indsendt
21. januar 2009
Først indsendt, der opfyldte QC-kriterier
21. januar 2009
Først opslået (Skøn)
22. januar 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. januar 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. januar 2009
Sidst verificeret
1. januar 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2009A123456
- H200343
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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