First Line Chemotherapy for Advanced Cancer

NCT ID: NCT01980810

Last Updated: 2016-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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albumin-bounded paclitaxel plus S-1

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

Group Type EXPERIMENTAL

albumin-bounded paclitaxel

Intervention Type DRUG

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

S-1

Intervention Type DRUG

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

Interventions

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albumin-bounded paclitaxel

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

Intervention Type DRUG

S-1

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

Intervention Type DRUG

Other Intervention Names

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Abraxane Paclitaxel Albumin-stabilized Nanoparticle Formulation TS-1

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Previous chemotherapy for advanced/metastatic disease
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Lin Yang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of medical oncology,Cancer hospital and institute,CAMS

Locations

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Department of Medical Oncology,Cancer Hostpital and Institute,CAMS

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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CH-GI-037-nab

Identifier Type: -

Identifier Source: org_study_id

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