Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model (NEXT-1)
28 décembre 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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)
Type d'étude
Observationnel
Inscription (Réel)
895
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Seoul, Corée, République de, 99999
- Samsung Medical Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
patients with treatment-refractory malignancy
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Response rate
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression Free Survival
Délai: 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
Délai: expected average of 3 years
|
To evaluate changes in the tumor's molecular profile on serial biopsies
|
expected average of 3 years
|
|
feasibility
Délai: expected average of 3 years
|
To establish n of 1 preclinical model for each patient whenever feasible
|
expected average of 3 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Won Ki Kang, MD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2015
Achèvement primaire (Réel)
1 décembre 2015
Achèvement de l'étude (Réel)
1 décembre 2015
Dates d'inscription aux études
Première soumission
10 février 2014
Première soumission répondant aux critères de contrôle qualité
14 mai 2014
Première publication (Estimation)
19 mai 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
29 décembre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 décembre 2015
Dernière vérification
1 décembre 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2013-10-017
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .