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

NCT01100801 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-06-22

No results posted yet for this study

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.

Conditions

  • Recurrent Gastric Cancer

Interventions

DRUG

TS-1 with cisplatin

DRUG

TS-1 with oxaliplatin

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    collaborator OTHER

  • Yonsei University

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Wei Peng Yong, MRCP, MB ChB · National University Hospital, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01100801 on ClinicalTrials.gov