Influence of Different Light Dose on the Adverse Effect of Swallowing for Esophageal Carcinoma
29. december 2021 opdateret af: The First Affiliated Hospital of Henan University of Science and Technology
A Phase III Randomized Controlled Study of the Effect of Different Light Doses on Adverse Outcomes of Swallowing in Esophageal Cancer
The purpose of this experiment is to study the alleviating effects and side effects of different laser irradiation doses on esophageal stricture of esophageal cancer in order to find the appropriate dose of light.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background: Photodynamic therapy (PDT) is one of the effective means for the control of esophageal stenosis in advanced esophageal cancer, among which the dose intensity of laser irradiation is one of the factors affecting the efficacy. This study aims to pursue the appropriate dose of light.
Aim: To compare the efficacy and safety of two groups of different laser irradiation doses for advanced esophageal cancer and esophageal stricture.
Methods: Fifty-seven patients were recruited for this study and randomly divided into two groups: single irradiation group and reirradiation group.Single irradiation group: 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Double irradiation group: 46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2.
Primary endpoints: ORR rates at 1 and 3 months, the quality of life
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
57
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Shegan Gao, MD, PhD
- Telefonnummer: 18638859977
- E-mail: gsg112258@163.com
Undersøgelse Kontakt Backup
- Navn: Tanyou Shan, MD, PhD
- Telefonnummer: 18537976669
- E-mail: shantanyoudoctor@163.com
Studiesteder
-
-
Henan
-
Luoyang, Henan, Kina, 471003
- The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
-
-
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
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- esophagus cancer
- 18-80 years old
- grade 3-4 dysphagia （Stoller classification）
- Non-eradicative second-line treatment
Exclusion Criteria:
- Ulcerative tumor
- Esophageal stenosis caused by radiotherapy
- Survival is less than 3 months
- Patients known to be allergic to photosensitizers
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: single irradiation group
46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
|
46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
|
|
Aktiv komparator: Double irradiation group
46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2.
|
46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
1 month objective response rate
Tidsramme: 1 month after photodynamic irradiation
|
Grade 3-4 dysphagia accounted
|
1 month after photodynamic irradiation
|
|
3 month objective response rate
Tidsramme: 3 month after photodynamic irradiation
|
Grade 3-4 dysphagia accounted
|
3 month after photodynamic irradiation
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
3 month Quality of Life score
Tidsramme: 3 month after photodynamic irradiation
|
3 month after photodynamic irradiation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Shegan Gao, MD, PhD, The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology
- Studieleder: Tanyou Shan, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- Ledende efterforsker: Caihong Dong, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- Ledende efterforsker: Wanying Li, MD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- Ledende efterforsker: Jiachun Sun, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- Ledende efterforsker: Mengxi Zhang, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
- Ledende efterforsker: Xiaozhi Yuan, MD, PhD, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
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
- Zeng R, Liu C, Li L, Cai X, Chen R, Li Z. Clinical Efficacy of HiPorfin Photodynamic Therapy for Advanced Obstructive Esophageal Cancer. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820930335. doi: 10.1177/1533033820930335.
- Yoon HY, Cheon YK, Choi HJ, Shim CS. Role of photodynamic therapy in the palliation of obstructing esophageal cancer. Korean J Intern Med. 2012 Sep;27(3):278-84. doi: 10.3904/kjim.2012.27.3.278. Epub 2012 Sep 1.
- Liu H, Liu Y, Wang L, Ruan X, Wang F, Xu D, Zhang J, Jia X, Liu D. Evaluation on Short-Term Therapeutic Effect of 2 Porphyrin Photosensitizer-Mediated Photodynamic Therapy for Esophageal Cancer. Technol Cancer Res Treat. 2019 Jan 1;18:1533033819831989. doi: 10.1177/1533033819831989.
- Lee HH, Choi MG, Hasan T. Application of photodynamic therapy in gastrointestinal disorders: an outdated or re-emerging technique? Korean J Intern Med. 2017 Jan;32(1):1-10. doi: 10.3904/kjim.2016.200. Epub 2017 Jan 1.
- Yano T, Minamide T, Takashima K, Nakajo K, Kadota T, Yoda Y. Clinical Practice of Photodynamic Therapy Using Talaporfin Sodium for Esophageal Cancer. J Clin Med. 2021 Jun 24;10(13):2785. doi: 10.3390/jcm10132785.
- National Health Commission Of The People's Republic Of China. Chinese guidelines for diagnosis and treatment of esophageal carcinoma 2018 (English version). Chin J Cancer Res. 2019 Apr;31(2):223-258. doi: 10.21147/j.issn.1000-9604.2019.02.01. No abstract available.
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 (Forventet)
1. januar 2022
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
30. juni 2023
Datoer for studieregistrering
Først indsendt
21. december 2021
Først indsendt, der opfyldte QC-kriterier
29. december 2021
Først opslået (Faktiske)
30. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ECPDT-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .