- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02883543
First-line Icotinib With Concurrent Radiotherapy for NSCLC With EGFR Mutation
29. august 2016 opdateret af: Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Phase III Study of Icotinib With Concurrent Radiotherapy as First-line Treatment for Unresectable/Oligometastasis NSCLC With EGFR Activating Mutation: a Prospective, Multicentre, Open-label, Randomised Study
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy.
The primary endpoint is progression-free survival, and the incidence of radiation-induced lung injury.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
330
Fase
- Fase 3
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:
- Aged 18 to 75 years
- Pathologically documented NSCLC
- Unresectable stage III or oligometastasis (less than three metastasis lesions, brain metastasis is not permitted) stage IV confirmed by CT and/or MRI
- Positive EGFR mutation confirmed by ARMS
- At least 3-month life expectancy
- KPS ≥ 70
- Adequate hematological values: hemoglobin ≥ 100 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L
- Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN
- Written informed consent before patient registration and any protocol-related procedures
Exclusion Criteria:
- Previous radiotherapy
- Received other investigational systemic drugs within 4 weeks prior to study entry
- Severe or uncontrolled systemic disease
- Active autoimmune disease, or a documented history of autoimmune/acquired immune disease, or a history of organ transplant
- Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
- Any other serious underlying medical (e.g. active uncontrolled infection, active gastric ulcer, uncontrolled seizures), psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
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: icotinib plus radiotherapy
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy.
|
Icotinib is orally administered three times per day.
5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy,
20f/4w for central lung cancer.
|
Aktiv komparator: icotinib
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib monotherapy.
|
Icotinib is orally administered three times per day.
|
Aktiv komparator: chemotherapy plus radiotherapy
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive chemotherapy plus concurrent radiotherapy.
|
5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy,
20f/4w for central lung cancer.
Chemotherapy is given by intravenous administration. Three regimens are available in this study. Regimen 1: etoposide 75mg/m2 d1-5 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 2: docetaxel 75mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 3: pemetrexed 500mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progressionsfri overlevelse
Tidsramme: 2 år
|
2 år
|
|
Incidence of radiation injure of the lungs
Tidsramme: 2 years
|
Measured according to NCI CTCAE v4.0
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Samlet overlevelse
Tidsramme: 5 år
|
5 år
|
|
Tumor response after icotinib induction
Tidsramme: 8 weeks
|
8 weeks
|
|
Quality of life
Tidsramme: 2 years
|
Measured by FACT-L
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Zhenzhou Yang, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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. juni 2016
Primær færdiggørelse (Forventet)
1. juni 2018
Studieafslutning (Forventet)
1. juni 2019
Datoer for studieregistrering
Først indsendt
8. august 2016
Først indsendt, der opfyldte QC-kriterier
29. august 2016
Først opslået (Skøn)
30. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RILI2016
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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 .
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