NCT01980810

Brief Summary

The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

1.4 years

First QC Date

November 5, 2013

Last Update Submit

June 11, 2016

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • response rate

    12 weeks

Secondary Outcomes (3)

  • progression free survival

    1 year

  • overall survival

    1 year

  • number of adverse event

    1 year

Study Arms (1)

albumin-bounded paclitaxel plus S-1

EXPERIMENTAL

arm 1:albumin-bounded paclitaxel 200mg iv d1 and S-1 80mg/m2/d po d1-10, repeated every 2 weeks,up to 9 cycles,then S-1 as single agent to treat to disease progression

Drug: albumin-bounded paclitaxelDrug: S-1

Interventions

albumin-bounded paclitaxelDRUG

200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles

Also known as: Abraxane, Paclitaxel Albumin-stabilized Nanoparticle Formulation
albumin-bounded paclitaxel plus S-1
S-1DRUG

40mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression

Also known as: TS-1
albumin-bounded paclitaxel plus S-1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
  • Adult patients \>=18 years of age
  • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
  • At least have one measurable disease(according to RECIST)
  • Adequate bone marrow,renal and liver function

You may not qualify if:

  • Previous chemotherapy for advanced/metastatic disease
  • Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Oncology,Cancer Hostpital and Institute,CAMS

Beijing, 100021, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Albumin-Bound PaclitaxelTaxesS 1 (combination)titanium silicide

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsEconomicsHealth Care Economics and Organizations

Study Officials

  • Lin Yang, MD

    Department of medical oncology,Cancer hospital and institute,CAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 11, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2016

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

CN(1)