Exploratory Study on the S-1 + Paclitaxel Chemotherapy fo... | NCT01756183

Studies
Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer

NCT01756183

Sponsor

Zhejiang Cancer Hospital

Status

Unknown status

Last Update Posted

Dec 25, 2012Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Surgically-Created Resection Cavity
Drug Safety

Interventions

S-1 + Paclitaxel Chemotherapy

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

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Sep 2013Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Nov 29, 2012

First Submission Date that Met QC Criteria

Dec 19, 2012

First Posted Date

Dec 25, 2012Estimated

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

Dec 19, 2012

Last Update Posted Date

Dec 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer

Detailed Description

To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out the optimal protocol for the peri-operative chemotherapy in the patients with gastric cancer.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
S-1 + Paclitaxel Chemotherapy	Experimental	S-1: 60mg twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. Paclitaxel: 150 mg/m2, iv, 3h, at D1	Drug: S-1 + Paclitaxel Chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-1 + Paclitaxel Chemotherapy	Drug	Dose of S-1: 60mg bid，Twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. Dose of Paclitaxel: 150 mg/m2, iv, 3h, at D1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
radical resection rate	radical resection rate	3 months

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	Number and degree of Adverse Events	6 months
reaction rate	the reaction rate of chemotherapy	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Unresectable gastric cancer as proven histologically (AJCC, Version 7) under any following condition: Unable radical excision due to the local metastasis or invasion Metastasis to the lymph node beside the abdominal aorta Non-extensive metastasis to liver (not more than three metastatic foci of radical excision)

Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
ECOG (Eastern Cooperative Oncology Group) : 0~2
Age: 18~75 years old
Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
Not participating in other study projects before and during the treatment
Signed the Informed Consent Form

Exclusion Criteria:

Not conforming to above inclusion criteria
Distal metastasis to lung, brain and bone (except the liver)
Ever operation on the stomach
Operation intolerance due to other systemic basic diseases
Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
Allergy to the drugs in this protocol
Pregnant or lactating women
Women at childbearing age and of pregnancy desire during the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided