NCT01100801

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

7.4 years

First QC Date

April 7, 2010

Last Update Submit

June 21, 2016

Conditions

Recurrent Gastric Cancer

Keywords

advancedmetastatic

Outcome Measures

Primary Outcomes (1)

  • Response Rate (RR)

    To determine the response rate of cisplatin/TS-1 and oxaliplatin/TS-1 combination in predicted 'responders'

    1 year

Study Arms (2)

TS-1 with cisplatin

EXPERIMENTAL

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.

Drug: TS-1 with cisplatin

TS-1 with oxaliplatin

EXPERIMENTAL

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.

Drug: TS-1 with oxaliplatin

Interventions

TS-1 with cisplatinDRUG
Also known as: TS-1 with cis-diamminedichloroplatinum
TS-1 with cisplatin
TS-1 with oxaliplatinDRUG
Also known as: TS-1 with 3rd-generation platinum analog
TS-1 with oxaliplatin

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore, Singapore

RECRUITING

Related Publications (2)

  • 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.

    PMID: 15221596BACKGROUND

  • Koizumi W. Chemotherapy for advanced gastric cancer: review of global and Japanese status. Gastrointest Cancer Res. 2007 Sep;1(5):197-203.

    PMID: 19262709BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Interventions

titanium silicideCisplatinOxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesOrganic Chemicals

Study Officials

  • Wei Peng Yong, MRCP, MB ChB

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Peng Yong, MRCP,MB ChB

CONTACT

65 6772 4670Wei_Peng_Yong@nuhs.edu.sg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 9, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

SG(1)