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

Primary Purpose

Surgically-Created Resection Cavity, Drug Safety

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

S-1 + Paclitaxel Chemotherapy

About this trial

This is an interventional treatment trial for Surgically-Created Resection Cavity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1 + Paclitaxel Chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

radical resection rate

Secondary Outcome Measures

Adverse Events

Number and degree of Adverse Events

reaction rate

the reaction rate of chemotherapy

overall survival time

the overall survival time

Full Information

NCT ID

NCT01756183

First Posted

November 29, 2012

Last Updated

December 19, 2012

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01756183

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Surgically-Created Resection Cavity, Drug Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

S-1 + Paclitaxel Chemotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

S-1 + Paclitaxel Chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

radical resection rate

Description

radical resection rate

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Number and degree of Adverse Events

Time Frame

6 months

Title

reaction rate

Description

the reaction rate of chemotherapy

Time Frame

2 months

Title

overall survival time

Description

the overall survival time

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

xiangdong Cheng, MD

Phone

+86 571 88122516

abdsurg@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

xiangdong Cheng, MD

Organizational Affiliation

Zhejiang Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

xiangdong Cheng, MD

Phone

+86 571 88122516

abdsurg@hotmail.com

First Name & Middle Initial & Last Name & Degree

xiangdong Cheng, MD

12. IPD Sharing Statement

Learn more about this trial

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

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