- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02738723
SBRT Compared With IMRT Concurrently With Chemotherapy in Treating Patients With LS-SCLC
10. april 2016 opdateret af: Xueqin Yang, Third Military Medical University
Stereotactic Body Radiation Therapy Compared With Intensity Modulated Radiation Therapy Concurrently With Chemotherapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the aim of this study is to evaluate the efficacy and safety of stereotactic body radiation therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung cancer
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
50
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Chongqing
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Chongqing, Chongqing, Kina, 400042
- Rekruttering
- Daping Hospital, Third Military Medical University
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Kontakt:
- Xueqin Yang, PH.D.
- Telefonnummer: 86-23-68757151
- E-mail: yangxueqin@hotmail.com
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Ledende efterforsker:
- Xueqin Yang, PH.D.
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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
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histologic or cytologic diagnosis of SCLC
- limited-stage disease is defined as disease confined to the ipsilateral hemithorax, which can be safely encompassed within a radiation field
- No prior chemotherapy, or radiotherapy
- Performance status of 0, 1, 2 on the ECOG criteria.
- At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative HCG test within 7 days prior to the study enrollment.
Exclusion Criteria:
- Non small cell lung cancer and carcinoid
- Supraclavicular lymphadenopathy
- Inability to comply with protocol or study procedures.
- Moderate and severe ventilation dysfunction
- Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Pregnant or breast-feeding.
- Enrollment in other study within 30 days
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 |
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Eksperimentel: GROUP 1
SBRT plus EP
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40 Gy for each patient.
Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.
Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks.
Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.
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Aktiv komparator: GROUP 2
IMRT plus EP
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Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks.
Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.
45 Gy for each patient,Accelerated twice-daily thoracic radiotherapy involved the administration of 1.5 Gy in 30 treatments over a period of three weeks.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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progression-free survival
Tidsramme: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 3 years
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Tumor responsrate
Tidsramme: forholdet mellem antallet af respondere og antallet af patienter, der kan vurderes for tumorrespons, vurderet op til 1 år
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forholdet mellem antallet af respondere og antallet af patienter, der kan vurderes for tumorrespons, vurderet op til 1 år
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Overall survival
Tidsramme: From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years
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From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Tidsramme: the first date of treatment to 3 months after the last dose of study drug
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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the first date of treatment to 3 months after the last dose of study drug
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Xueqin Yang, PHD, Daping Hospital, Third Military Medical University
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
- Turrisi AT 3rd, Kim K, Blum R, Sause WT, Livingston RB, Komaki R, Wagner H, Aisner S, Johnson DH. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71. doi: 10.1056/NEJM199901283400403.
- Li C, Xiong Y, Zhou Z, Peng Y, Huang H, Xu M, Kang H, Peng B, Wang D, Yang X. Stereotactic body radiotherapy with concurrent chemotherapy extends survival of patients with limited stage small cell lung cancer: a single-center prospective phase II study. Med Oncol. 2014 Dec;31(12):369. doi: 10.1007/s12032-014-0369-x. Epub 2014 Nov 22.
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 2016
Primær færdiggørelse (Forventet)
1. januar 2019
Studieafslutning (Forventet)
1. januar 2020
Datoer for studieregistrering
Først indsendt
25. marts 2016
Først indsendt, der opfyldte QC-kriterier
10. april 2016
Først opslået (Skøn)
14. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STIM
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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