Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model (NEXT-1)
28. desember 2015 oppdatert av: Jeeyun Lee, Samsung Medical Center
Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model: The Master Protocol
The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.
To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling and receive molecular profile directed treatments.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
This study nickname is NEXT-1 trial(Next pErsonalized cancer tX with mulTi). A single-center, open label trial to analysis of genetic information in advanced cancer.
If the target is to be confirmed by molecular profile, the subgroup is going to Umbrella trial type.
defined below: NEXT 1 trial is screening and feasibility -> NEXT trial is BASKET/umbrella study screening protocol(Molecular screening prolongs survival)->NEXT-1.1(gastric cancer),NEXT-1.2(colorectal cancer),NEXT-1.3(biliary tract cancer/pancreatic cancer),NEXT-1.4(Rare cancer),NEXT-1.5(genitourinary cancer)
Studietype
Observasjonsmessig
Registrering (Faktiske)
895
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Seoul, Korea, Republikken, 99999
- Samsung Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
patients with treatment-refractory malignancy
Beskrivelse
Inclusion Criteria:
- pathologically confirmed metastatic malignancy
- Written informed consent
Exclusion Criteria:
- patients who do not agree with biopsy
- patients who do not have enough tissue for acquisition
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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gastric cancer
This study will recruit a total of 130 gastric cancer patients.
It is expected to recruit about 250 gastric cancer patients per year.
Since the incidence of each mutation is low, the different types of mutations are assumed to be mutually exclusive.
So, about 30% of these patients are expected to have a mutation with a target drug.
Overall response (OR) is the primary endpoint of this study.
OR rate (ORR) will be compared between the group (called targeted group) of patients who have a mutation with a target drug and that (called untargeted group) of patients who have no mutation.
The ORR is expected to be about 25% for the targeted group and about 5% for the untargeted group.
With N=130 gastric cancer patients, about 39 patients will belong to the targeted group and about 91 will belong to the untargeted group.
The chi-square test with a 2-sided alpha=5% has 89% of power.
The study on gastric cancer will take 7 months for patient accrual.
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colorectal cancer
This study will recruit a total of 130 colorectal cancer patients.
It is expected to recruit about 300 colorectal cancer patients per year.
About 25% of these patients are expected to have a mutation with a target drug.
ORR will be compared between the targeted group and the untargeted group.
The median ORR is expected to be about 25% for the targeted group and about 5% for the untargeted group.
With N=130 colorectal cancer patients, about 33 patients will belong to the targeted group and about 97 will belong to the untargeted group.
The chi-square test with a 2-sided alpha=5% has 87% of power.
The study on colorectal cancer will take about 6 months for accrual.
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biliary tract cancer/pancreatic cancer
This study will recruit a total of 78 biliary tract cancer/pancreatic cancer patients.
It is expected to recruit about 100 biliary tract cancer/pancreatic cancer patients per year.
About 20% of these patients are expected to have a mutation with a target drug.
ORR will be compared between the targeted group and the untargeted group.
The ORR is expected to be about 35% for the targeted group and about 5% for the untargeted group.
With N=78 biliary tract cancer/pancreatic cancer patients, about 16 patients will belong to the targeted group and about 62 will belong to the untargeted group.
The chi-square test with a 2-sided alpha=5% has 87% of power.
The study on biliary tract cancer/pancreatic cancer will take about 7 months for accrual.
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Rare cancer
Rare cancer is hepatocellular carcinoma, melanoma and neuroendocrine tumor.
This study will recruit a total of 87 hepatocellular carcinoma/rare cancer patients.
It is expected to recruit about 150 biliary tract cancer/pancreatic cancer patients per year.
About 25% of these patients are expected to have a mutation with a target drug.
ORR will be compared between the targeted group and the untargeted group.
The ORR is expected to be about 30% for the targeted group and about 5% for the untargeted group.
With N=87 biliary tract cancer/pancreatic cancer patients, about 22 patients will belong to the targeted group and about 65 will belong to the untargeted group.
The chi-square test with a 2-sided alpha=5% has 86% of power.
The study on biliary tract cancer/pancreatic cancer will take about 7 months for accrual.
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genitourinary cancer
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Response rate
Tidsramme: expected average of 3 years
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To compare response rate (RR) (per RECIST 1.1) in patient cohort with molecularly matched treatment (in practice or in the context of clinical trials) versus RR in patient cohort with non-matched treatment based on molecular profiling
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expected average of 3 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Progression Free Survival
Tidsramme: expected average of 3 years
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To compare PFS in patient cohort with molecularly matched treatment (in practice or in the context of clinical trials) versus PFS in patient cohort with non-matched treatment based on molecular profiling
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expected average of 3 years
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feasibility
Tidsramme: expected average of 3 years
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To evaluate changes in the tumor's molecular profile on serial biopsies
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expected average of 3 years
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feasibility
Tidsramme: expected average of 3 years
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To establish n of 1 preclinical model for each patient whenever feasible
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expected average of 3 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Won Ki Kang, MD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2015
Primær fullføring (Faktiske)
1. desember 2015
Studiet fullført (Faktiske)
1. desember 2015
Datoer for studieregistrering
Først innsendt
10. februar 2014
Først innsendt som oppfylte QC-kriteriene
14. mai 2014
Først lagt ut (Anslag)
19. mai 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2013-10-017
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