- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01798251
XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach
3. maj 2013 opdateret af: BAI Yuxian, Harbin Medical University
A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yuxian BAI, PhD
- Telefonnummer: 86 451 86298265
- E-mail: bai_yuxian@126.com
Undersøgelse Kontakt Backup
- Navn: Hong SUI, PhD
- Telefonnummer: 86 13936592698
- E-mail: doctorsui2003@126.com
Studiesteder
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150000
- Rekruttering
- The tumor hospital of Harbin medical university
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Ledende efterforsker:
- Yuxian BAI, PhD
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Kontakt:
- Yuxian BAI, PhD
- Telefonnummer: 86 451 86298265
- E-mail: bai_yuxian@126.com
-
Kontakt:
- Hong SUI, PhD
- Telefonnummer: 86 13936592698
- E-mail: doctorsui2003@126.com
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Underforsker:
- Hong SUI, PhD
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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
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Ages Eligible for Study: 65 Years or older
- Genders Eligible for Study: Both
- The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- Histologically confirmed gastric adenocarcinoma(including LAUREN type).
- Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
- chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
- Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.
- No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
- Able to accept oral medication
- Compliance with protocol
Exclusion Criteria:
- Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
- Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
- Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
- clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
- Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
- Organ transplantation requires immunosuppressive treatment.
- Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
- Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.
- Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
- Allergy to Oxaliplatin or any study medication ingredients.
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: XELOX-X
XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance. X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance. |
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
Andre navne:
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
Andre navne:
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Aktiv komparator: XELOX
XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks.
Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
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Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
Andre navne:
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Progression Free Survival (PFS)
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 12 months
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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 12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
samlet overlevelse (OS)
Tidsramme: fra randomiseringsdatoen til dødsfald uanset årsag eller op til 1 år
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fra randomiseringsdatoen til dødsfald uanset årsag eller op til 1 år
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bivirkninger (AE)
Tidsramme: fra randomiseringsdato til 28 dage efter sidste kemodosis
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fra randomiseringsdato til 28 dage efter sidste kemodosis
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Response Rate (RR)
Tidsramme: evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks
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evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
health-related quality of life (HRQOL)
Tidsramme: evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage
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evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage
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excision repair cross-complementing 1(ERCC1) expression
Tidsramme: assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment
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quantitative real-time reverse transcriptase polymerase chain reaction (PCR) assays were performed to determine ERCC1 mRNA expression in tumor tissue.
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assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment
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K-ras gene type
Tidsramme: assess after randomization and before the first treatment
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Genomic Deoxyribonucleic acid (DNA) is extracted from tumor tissue, direct sequencing technique is used to test K-ras gene type(mutation or wild).
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assess after randomization and before the first treatment
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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: Yuxian BAI, PhD, The tumor hospital of Harbin 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. december 2012
Primær færdiggørelse (Forventet)
1. december 2014
Studieafslutning (Forventet)
1. december 2015
Datoer for studieregistrering
Først indsendt
13. december 2012
Først indsendt, der opfyldte QC-kriterier
22. februar 2013
Først opslået (Skøn)
25. februar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. maj 2013
Sidst verificeret
1. maj 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i maven
- Adenocarcinom
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Capecitabin
- Oxaliplatin
Andre undersøgelses-id-numre
- CGOG20120101009
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 Mavekræft
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Medtronic - MITGAfsluttet
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Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal ærmegatrektomi | Mavebånd | Bypass, GastricForenede Stater
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DuomedAktiv, ikke rekrutterendeFedme | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgien
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Olympus Corporation of the AmericasUnity Health TorontoAfsluttet
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North Dakota State UniversityNational Institutes of Health (NIH)AfsluttetRoux en Y Gastric Bypass OperationForenede Stater
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Rijnstate HospitalAfsluttetRoux-en-Y Gastric Bypass | Mavetømning | Bariatrisk kirurgiHolland
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Wageningen UniversityRijnstate HospitalUkendtRoux-en-Y Gastric BypassHolland
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetRoux en Y Gastric BypassForenede Stater
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Rijnstate HospitalAfsluttet
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetSleeve Gastrectomy | Roux en Y Gastric BypassForenede Stater
Kliniske forsøg med Oxaliplatin
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Xijing HospitalUkendt
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Lin ChenUkendtGastrisk AdenocarcinomKina
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Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetLivmoderhalskræft | Primær peritoneal kræftForenede Stater, Canada
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Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetLivmoderhalskræftForenede Stater, Canada
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Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)AfsluttetHoved- og halskræftForenede Stater
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St. Jude Children's Research HospitalNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor i barndommen, protokolspecifikForenede Stater
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University of California, DavisNational Cancer Institute (NCI)AfsluttetStadie IV brystkræftForenede Stater
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University of ChicagoNational Cancer Institute (NCI)AfsluttetBlærekræft | Overgangscellekræft i nyrebækkenet og urinlederenForenede Stater, Canada
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Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetEndometriecancerForenede Stater
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European Organisation for Research and Treatment...AfsluttetBrystkræftFrankrig, Belgien, Slovenien, Israel, Det Forenede Kongerige, Tyskland, Østrig