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Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model (NEXT-1)

28. december 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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)

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

895

Kontakter og lokationer

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

Studiesteder

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
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.
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.
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.
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.
genitourinary cancer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response rate
Tidsramme: expected average of 3 years
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
expected average of 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival
Tidsramme: expected average of 3 years
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
expected average of 3 years
feasibility
Tidsramme: expected average of 3 years
To evaluate changes in the tumor's molecular profile on serial biopsies
expected average of 3 years
feasibility
Tidsramme: expected average of 3 years
To establish n of 1 preclinical model for each patient whenever feasible
expected average of 3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Samsung Medical Center

Efterforskere

  • Studiestol: Won Ki Kang, MD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. februar 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

10. februar 2014

Først indsendt, der opfyldte QC-kriterier

14. maj 2014

Først opslået (Skøn)

19. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2013-10-017

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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