Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model (NEXT-1)
28. Dezember 2015 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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)
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
895
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Seoul, Korea, Republik von, 99999
- Samsung Medical Center
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
patients with treatment-refractory malignancy
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Zeitperspektiven: Interessent
Kohorten und Interventionen
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Response rate
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Progression Free Survival
Zeitfenster: 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
Zeitfenster: expected average of 3 years
|
To evaluate changes in the tumor's molecular profile on serial biopsies
|
expected average of 3 years
|
|
feasibility
Zeitfenster: expected average of 3 years
|
To establish n of 1 preclinical model for each patient whenever feasible
|
expected average of 3 years
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Won Ki Kang, MD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2015
Primärer Abschluss (Tatsächlich)
1. Dezember 2015
Studienabschluss (Tatsächlich)
1. Dezember 2015
Studienanmeldedaten
Zuerst eingereicht
10. Februar 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. Mai 2014
Zuerst gepostet (Schätzen)
19. Mai 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
29. Dezember 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. Dezember 2015
Zuletzt verifiziert
1. Dezember 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2013-10-017
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Metastasierender Krebs
-
Union Hospital, Tongji Medical College, Huazhong...RekrutierungUterine Cervical Neoplasms, Recurrent; Uterine Cervical Neoplasms, Metastatic; Vulvar Neoplasms; Vaginal NeoplasmsChina