Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
11. august 2014 opdateret af: Betta Pharmaceuticals Co., Ltd.
Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
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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Beijing
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Beijing, Beijing, Kina, 100191
- Peking University Third Hospital
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Beijing, Beijing, Kina, 100021
- Chinese Academy of Medical Sciences Cancer Hospital
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Beijing, Beijing, Kina, 100039
- People's Liberation Army 307 Hospital
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Beijing, Beijing, Kina, 100730
- Beijing Union Medical College Hospital
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Guangdong
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Dongguan, Guangdong, Kina, 523059
- Dongguan City People's Hospital
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Guangzhou, Guangdong, Kina, 510515
- Nanfang Hospital
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Guangzhou, Guangdong, Kina, 510060
- Sun Yat-sen Cancer Hospital
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Guangxi
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Nanning, Guangxi, Kina, 530021
- Guangxi Zhuang Autonomous Region People's Hospital
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150081
- Cancer Hospital of Harbin Medical University
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Henan
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Zhengzhou, Henan, Kina, 450052
- First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Kina, 430030
- Tongji Hospital
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Hunan
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Changsha, Hunan, Kina, 410013
- Hunan Provincial Tumor Hospital
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Jiangsu
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Nanjing, Jiangsu, Kina, 210009
- Jiangsu Cancer Hospital
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Nantong, Jiangsu, Kina, 226361
- Nantong Tumor Hospital
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Jiangxi
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Nanchang, Jiangxi, Kina, 330029
- Jiangxi Provincial Cancer Hospital
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Jilin
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Changchun, Jilin, Kina, 130012
- Tumor Hospital of Jilin Province
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Liaoning
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Shenyang, Liaoning, Kina, 110042
- Liaoning Provincial Tumor Hospital
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Shanghai
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Shanghai, Shanghai, Kina, 200032
- Fudan University Cancer Hospital
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Shanghai, Shanghai, Kina, 200030
- Shanghai Chest Hospital
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Shanxi
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Taiyuan, Shanxi, Kina, 030013
- Shanxi Tumor Hospital
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Sichuan Provincial Tumor Hospital
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Tianjin
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Tianjin, Tianjin, Kina, 300060
- Tianjin Cancer Hospital
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Xinjiang
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Wulumuqi, Xinjiang, Kina, 830000
- First Affiliated Hospital of Xinjiang Medical University
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Yunnan
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Kunming, Yunnan, Kina, 650118
- Tumor Hospital of Yunnan Province
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, Kina, 310006
- Hangzhou First People's Hospital
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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 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation
- No previous systemic anticancer therapy
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
- ECOG Performance Status of 0 to 1
Exclusion Criteria:
- Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab
- Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- Known severe hypersensitivity to icotinib or any of the excipients of this product
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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Aktiv komparator: Chemoradiotherapy
Etoposide 50mg/m2, ivgtt, d1-d5, cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles, while chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times).
Progressive patients will be administered oral icotinib 125 mg three times daily.
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Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
Andre navne:
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Eksperimentel: Icotinib with concurrent radiotherapy
Chest radiotherapy (total dose 60-66Gy, 2Gy per time, once a day, five times a week, a total of 30-33 times), while icotinib 125mg three times daily (375 mg per day) by mouth.
Maintenance icotinib will be administered after radiotherapy.
Progressive patients will receive chemotherapy, using the platinum-based two-drug chemotherapy regimen.
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Icotinib: 125 mg is administered orally three times per day.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Progressionsfri overlevelse
Tidsramme: 24 måneder
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24 måneder
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Samlet overlevelse
Tidsramme: 36 måneder
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36 måneder
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Objektiv svarprocent
Tidsramme: 8 uger
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8 uger
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Adverse events
Tidsramme: 54 months
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54 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: Lvhua Wang, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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. august 2014
Primær færdiggørelse (Forventet)
1. august 2018
Studieafslutning (Forventet)
1. februar 2019
Datoer for studieregistrering
Først indsendt
11. august 2014
Først indsendt, der opfyldte QC-kriterier
11. august 2014
Først opslået (Skøn)
13. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BD-IC-IV66
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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