search
Back to results

First Line Chemotherapy for Advanced Cancer (GC-A-003)

Primary Purpose

Gastric Cancer

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
albumin-bounded paclitaxel
S-1
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medical Oncology,Cancer Hostpital and Institute,CAMS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

albumin-bounded paclitaxel plus S-1

Arm Description

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

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

progression free survival
overall survival
number of adverse event

Full Information

First Posted
November 5, 2013
Last Updated
June 11, 2016
Sponsor
Chinese Academy of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01980810
Brief Title
First Line Chemotherapy for Advanced Cancer
Acronym
GC-A-003
Official Title
Pase 2 Study of Albumin-bounded Paclitaxel Plus S-1 as First-line Chemotherapy for Locally Advanced or Metastatic Gastric or Gastro-esophageal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
recruit too slowly
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
albumin-bounded paclitaxel plus S-1
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
albumin-bounded paclitaxel
Other Intervention Name(s)
Abraxane, Paclitaxel Albumin-stabilized Nanoparticle Formulation
Intervention Description
200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
TS-1
Intervention Description
40mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression
Primary Outcome Measure Information:
Title
response rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
1 year
Title
overall survival
Time Frame
1 year
Title
number of adverse event
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Yang, MD
Organizational Affiliation
Department of medical oncology,Cancer hospital and institute,CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology,Cancer Hostpital and Institute,CAMS
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Learn more about this trial

First Line Chemotherapy for Advanced Cancer

We'll reach out to this number within 24 hrs