- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01100801
A Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients (3G)
A Phase II Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients
This is an open, non-randomized, multicenter Phase II study evaluating cisplatin plus TS-1 or oxaliplatin plus TS-1 as first-line therapy in predicted 'responder' to platinum and fluoropyrimidine.
This study is planned in 3 centers in Singapore and Korea. A total of 30 subjects will be enrolled into each treatment arms. Each centers will recruit 15-25 subjects predicted to be 'responder' to platinum and fluoropyrimidine. The study will consist of a prescreening period, a screening period and a treatment period. A fresh tumour biopsy sample will be obtained during the prescreening period for gene expression profiling.
As this is a genomics guided trial, obtaining tissue biopsies is vital to the conduct of the trial.
Patients will have the primary in situ (requirement for entry into trial), endoscopic biopsy performed prior to 1st cycle.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Gastric cancer is the world's second leading cause of cancer death. For patients with unresectable disease or recurrent disease after surgery, the main therapeutic option is chemotherapy. Chemotherapy can improve survival and quality of life in patients with advanced disease when compared with best supportive care alone.
Despite a large number of randomized trials, there is no consensus as to the best agent or regimen. In general, combination chemotherapy regimens provide higher response rates than do single agent, however, this translates into only a modest improvement in outcome with a trade off in increased treatment toxicities. The key challenge in managing patients with advanced gastric cancer is to identify the appropriate drugs for patients who might benefit for palliative chemotherapy.
Gastric cancer is a heterogeneous disease with differing chemosensitivities to anti-cancer drugs. Current selection of standard therapy is often empirical. Gene expression profiling has been shown to have the capability to dissect this heterogeneity allowing for sub-classification and risk-stratification of cancers according to their biological features and clinical outcome. Utilising gene expression data coupled with in-vitro, in-vivo or clinical response data is a promising strategy that may enable clinicians to match the right drug to the right patient.
The purpose of the study are:
- Assess the feasibility of genomic-guided therapy
- Evaluated treatment response of standard-of-care chemotherapy in an enriched patient groups defined as 'responder' based on genomic-guided therapy
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
-
Singapore, Singapore
- Rekruttering
- National University Hospital
-
Kontakt:
- Wei Peng Yong, MRCP, MB ChB
- Telefonnummer: 65 6772 4670
- E-mail: Wei_Peng_Yong@nuhs.edu.sg
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically documented locally advanced, metastatic or recurrent gastric cancer for which convention therapy of a platinum/fluoropyrimidine combination is indicated
- Predicted 'responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in-vitro sensitivity array
- At least one measurable defined by RECIST
- Age >=21 years old
- Performance status (ECOG) 0-2
- Life expectancy >3 months
- No significant problems for oral intake and drug administration
- Adequate organ functions:
bone marrow function (ANC = 1,500/uL, Platelet = 100,000/ uL, Hb = 8.0 g/dl) renal function: serum creatinine = UNL (if serum creatinine > ULN, creatinine clearance should be = 60 mL/min) hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x ULN without liver metastasis, total bilirubin < 3x ULN and AST/ALT levels < 5 x ULN with liver metastasis)
- Recovery from relevant toxicity to previous treatment before study entry
- Ability to understand and willingness to sign a written informed consent before study entry
Exclusion Criteria:
- Prior chemotherapy for gastric cancer except neoadjuvant or adjuvant systemic therapy if terminated at least 6 months before the start of treatment in this study
- Prior radiotherapy was administered to target lesions selected for this study
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- Presence of symptomatic or progressing CNS metastasis
- Serious illness or medical conditions:
Congestive heart failure (NYHA class III or IV), unstable angina or myocardial infarction within the past 3 months Hepatic cirrhosis (= Child class B) Psychiatric disorder that may interfere with protocol compliance Active infection
- Known hypersensitivity to platinum or fluoropyrimidine.
- Pregnant or lactating woman. Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
- Predicted 'non-responder' to platinum and fluoropyrimidine based on tumour expression signature derived from in- vitro sensitivity array
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: TS-1 with cisplatin
Chemotherapy injection (60mg/m2 cisplatin) will be given on day 1. 14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days. |
Andre navne:
|
|
Eksperimentel: TS-1 with oxaliplatin
Chemotherapy injection (100mg/m2 oxaliplatin) will be given on day 1. 14 days of Oral TS-1 (40mg/m²) will be prescribed. Subjects will take it after breakfast and evening meal on Day 1-14 of a 3-weekly treatment cycle. Each cycle is about 21 days. |
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Response Rate (RR)
Tidsramme: 1 year
|
To determine the response rate of cisplatin/TS-1 and oxaliplatin/TS-1 combination in predicted 'responders'
|
1 year
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Arai W, Hosoya Y, Hyodo M, Yokoyama T, Hirashima Y, Yasuda Y, Nagai H, Shirasaka T. Alternate-day oral therapy with TS-1 for advanced gastric cancer. Int J Clin Oncol. 2004 Jun;9(3):143-8. doi: 10.1007/s10147-004-0381-9.
- Koizumi W. Chemotherapy for advanced gastric cancer: review of global and Japanese status. Gastrointest Cancer Res. 2007 Sep;1(5):197-203.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GA01/01/10
- 2010/00064 (Anden identifikator: NHG Domain Specific Review Board)
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 Tilbagevendende mavekræft
-
Ohio State UniversityMerck Sharp & Dohme LLCIkke rekrutterer endnuRecurrent Respiratory Papillomatosis (RRP)Forenede Stater
-
National Cancer Institute (NCI)Ikke rekrutterer endnuRecidiverende platinfølsomt tuba fallopii højgradigt serøst adenokarcinom | Recidiverende Platinfølsom Ovarie Højgradigt Serøs Adenokarcinom | Recurrent Platinum-Sensitive Primary Peritoneal High Grade Serous Adenocarcinoma | Recurrent Platinum-Sensitive Endometrioid Adenokarcinom i Æggelederen og andre forhold
-
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
-
Medtronic - MITGAfsluttet
-
North Dakota State UniversityNational Institutes of Health (NIH)AfsluttetRoux en Y Gastric Bypass OperationForenede Stater
-
DuomedAktiv, ikke rekrutterendeFedme | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgien
-
Olympus Corporation of the AmericasUnity Health TorontoAfsluttet
-
Jessa HospitalIkke rekrutterer endnu
-
Wageningen UniversityRijnstate HospitalUkendtRoux-en-Y Gastric BypassHolland
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetRoux en Y Gastric BypassForenede Stater
Kliniske forsøg med TS-1 with cisplatin
-
Kyungpook National University HospitalUkendtMavekræftKorea, Republikken
-
Asan Medical CenterNational Cancer Center, Korea; Chonbuk National University Hospital; Samsung... og andre samarbejdspartnereAfsluttetAvanceret mavekræftKorea, Republikken
-
Yonsei UniversityAfsluttet
-
Yonsei UniversityAfsluttetGastrisk AdenocarcinomKorea, Republikken
-
National University Hospital, SingaporeAktiv, ikke rekrutterendeKræft | LeverdysfunktionSingapore
-
Min-Hee RyuAfsluttetMavekræftKorea, Republikken
-
Yonsei UniversityAfsluttet
-
Taiho Pharmaceutical Co., Ltd.Afsluttet
-
Chonnam National University HospitalChungbuk National University; Chungnam National University; Chonbuk National...AfsluttetHoved- og halskræftKorea, Republikken
-
Taisho Pharmaceutical Co., Ltd.Afsluttet