Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

26. maj 2010 opdateret af: Chinese PLA General Hospital

Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100853
        • Chinese Pla General Hospital

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female patients aged over 18 years
  • Histologically proven lung adenocarcinoma
  • clinical stage IIIB/IV
  • ECOG performance status 0-2
  • Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma
  • At least one measurable lesion (according to RECIST)
  • Provision of written informed consent
  • Life expectancy of at least 12 weeks

Exclusion Criteria:

  • History of malignant disease.
  • Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
  • Expected life expectancy less than 2 months
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
  • Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

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: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: first-line erlotinib
erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment
Medicin: Erlotinib
Erlotinib 150 mg/d per os until proven disease progression
Medicin: Docetaxel
Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
Medicin: Cisplatin
cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
Medicin: Docetaxel
Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
Medicin: Cisplatin
Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
Medicin: Erlotinib
Erlotinib 150 mg/d per os as second-line treatment
Aktiv komparator: second-line erlotinib
docetaxel/cisplatin in first-line treatment and erlotinib in second-line treatment
Medicin: Erlotinib
Erlotinib 150 mg/d per os until proven disease progression
Medicin: Docetaxel
Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
Medicin: Cisplatin
cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
Medicin: Docetaxel
Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
Medicin: Cisplatin
Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
Medicin: Erlotinib
Erlotinib 150 mg/d per os as second-line treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Overall survival
Tidsramme: three year
three year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
livskvalitet under førstelinjebehandlingen
Tidsramme: hver 3. uge under førstelinjebehandling
hver 3. uge under førstelinjebehandling
progression-free survival during the first-line treatment
Tidsramme: 1 year
1 year
progression-free time during the second-line treatment
Tidsramme: 2 years
2 years
quality of life during the second-line therapy
Tidsramme: every 3 weeks during the second-line therapy
every 3 weeks during the second-line therapy
response rates during the first-line treatment
Tidsramme: at 6 months from treatment initiation
at 6 months from treatment initiation
response rates during the second-line treatment
Tidsramme: every 3 weeks during the treament, and and every 6 weeks thereafter
every 3 weeks during the treament, and and every 6 weeks thereafter
toxicity during the first-line treatment
Tidsramme: at 12 months from treatment initiation
at 12 months from treatment initiation
toxicity during the second-line treatment
Tidsramme: end of study
end of study
preditive and prognostic markers for chemotherapy or erlotinib
Tidsramme: end of study
tissues for markers analysis are acquired during diagnosis procedure with informed consent.
end of study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese PLA General Hospital

Efterforskere

  • Studiestol: Liang-An Chen, M.D., Ph.D., Chinese PLA general hospital, Beijing, China

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 2010

Primær færdiggørelse (Forventet)

1. juni 2013

Studieafslutning (Forventet)

1. juni 2015

Datoer for studieregistrering

Først indsendt

25. maj 2010

Først indsendt, der opfyldte QC-kriterier

26. maj 2010

Først opslået (Skøn)

27. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. maj 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2010

Sidst verificeret

1. april 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PLAGH-TKIs

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 .

Kliniske forsøg med Neoplasmer, lunge

Kliniske forsøg med Erlotinib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Romania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner