NCT02951091

Brief Summary

In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment. The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 30, 2024

Status Verified

January 1, 2024

Enrollment Period

5.9 years

First QC Date

October 28, 2016

Last Update Submit

December 26, 2024

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    progression free survival

    6 weeks

Study Arms (2)

biomarker group

EXPERIMENTAL

400 Her-2 (-) metastatic/recurrent gastric cancer patients will be centrally screened for druggable targets \[Epstein-Barr virus, Microsatellite instability, HER2, EGFR, c-MET, and PTEN\] by immunohistochemistry and in situ hybridization during first line chemotherapy. At the time of second line treatment, patients will be randomized to the biomarker vs control group as 4: 1 ratio. The biomarker group will be offered for entry into a specific protocol based on their molecular cohort and treated with specific targeted agents in combination with weekly paclitaxel; 1) EGFR cohort (EGFR 2+ or EGFR 3+) for pan-ERBB inhibitor (afatinib), 2)PTEN loss cohort (PTEN score less than 100) for PIK3CB inhibitor (GSK2636771), 3) PD-L1 positive, MSI-high, or EBV positive cases for nivolumab, 4) none for weekly paclitaxel.

Other: biomarker screening

control group

ACTIVE COMPARATOR

Patients will be randomized to the biomarker vs control group (standard of care; paclitaxel) as 4:1 ratio.

Other: biomarker screening

Interventions

biomarker screeningOTHER

immunohistochemistry and in situ hybridization

biomarker groupcontrol group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
  • Eastern Cooperative Oncology Group performance status of 0 to 1
  • Male or female; ≥ 19 years of age
  • On or progression after 1st line palliative chemotherapy
  • Subjects with evaluable lesion (using RECIST 1.1 criteria)
  • Subjects who meet the following criteria:
  • Absolute neutrophil count ≥ 1000 /µL
  • Platelet count ≥ 75,000/ µL
  • Serum creatinine \< 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min
  • aspartate aminotransferase and alanine transaminase 3 x upper limit of normal

You may not qualify if:

  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Lee CK, Kim HS, Jung M, Kim H, Bae WK, Koo DH, Jeung HC, Park SR, Hwang IG, Zang DY, Lee HW, Park S, Nam CM, Chung HC, Rha SY. Open-Label, Multicenter, Randomized, Biomarker-Integrated Umbrella Trial for Second-Line Treatment of Advanced Gastric Cancer: K-Umbrella Gastric Cancer Study. J Clin Oncol. 2024 Jan 20;42(3):348-357. doi: 10.1200/JCO.23.00971. Epub 2023 Oct 26.

    PMID: 37883723DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Sun Young Rha, Ph.D

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Biomarker-integrated multi-arm with shared standard of care (SOC) control arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 1, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2021

Study Completion

March 1, 2024

Last Updated

December 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)