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A Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients (3G)

Primary Purpose

Recurrent Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
TS-1 with cisplatin
TS-1 with oxaliplatin
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Gastric Cancer focused on measuring advanced, metastatic

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TS-1 with cisplatin

TS-1 with oxaliplatin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Response Rate (RR)
To determine the response rate of cisplatin/TS-1 and oxaliplatin/TS-1 combination in predicted 'responders'

Secondary Outcome Measures

Full Information

First Posted
April 7, 2010
Last Updated
June 21, 2016
Sponsor
National University Hospital, Singapore
Collaborators
National Cancer Centre, Singapore, Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01100801
Brief Title
A Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients
Acronym
3G
Official Title
A Phase II Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
National Cancer Centre, Singapore, Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Gastric Cancer
Keywords
advanced, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TS-1 with cisplatin
Arm Type
Experimental
Arm Description
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.
Arm Title
TS-1 with oxaliplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TS-1 with cisplatin
Other Intervention Name(s)
TS-1 with cis-diamminedichloroplatinum
Intervention Type
Drug
Intervention Name(s)
TS-1 with oxaliplatin
Other Intervention Name(s)
TS-1 with 3rd-generation platinum analog
Primary Outcome Measure Information:
Title
Response Rate (RR)
Description
To determine the response rate of cisplatin/TS-1 and oxaliplatin/TS-1 combination in predicted 'responders'
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Peng Yong, MRCP,MB ChB
Phone
65 6772 4670
Email
Wei_Peng_Yong@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Peng Yong, MRCP, MB ChB
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Peng Yong, MRCP, MB ChB
Phone
65 6772 4670
Email
Wei_Peng_Yong@nuhs.edu.sg

12. IPD Sharing Statement

Citations:
PubMed Identifier
15221596
Citation
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.
Results Reference
background
PubMed Identifier
19262709
Citation
Koizumi W. Chemotherapy for advanced gastric cancer: review of global and Japanese status. Gastrointest Cancer Res. 2007 Sep;1(5):197-203.
Results Reference
background

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A Study of Genomic-guided 'Standard-of-care' Chemotherapy for in Advanced Gastric Cancer Patients

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