First Line Chemotherapy for Advanced Cancer | NCT01980810

Studies
First Line Chemotherapy for Advanced Cancer

NCT01980810

Sponsor

Chinese Academy of Medical Sciences

Status

Terminated

Last Update Posted

Jun 14, 2016Estimated

Enrollment

36Actual

Phase

Phase 2

Conditions

Gastric Cancer

Interventions

albumin-bounded paclitaxel
S-1

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruit too slowly

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2016Actual

First Submitted Date

Nov 5, 2013

First Submission Date that Met QC Criteria

Nov 5, 2013

First Posted Date

Nov 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2016

Last Update Posted Date

Jun 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 paclitaxel Drug: S-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
albumin-bounded paclitaxel	Drug	200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles	albumin-bounded paclitaxel plus S-1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response rate		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
progression free survival		1 year
overall survival		1 year
number of adverse event

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lin Yang, MD	Department of medical oncology,Cancer hospital and institute,CAMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Oncology,Cancer Hostpital and Institute,CAMS		Beijing		100021	China

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068196	Albumin-Bound Paclitaxel
D013660	Taxes
C079198	S 1 (combination)
C103828	titanium silicide

Ancestor Terms

ID	Term
D017239	Paclitaxel
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840

Browse Leaves

Not provided

Browse Branches

Not provided