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

Drug Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01756183
• Other study ID #: SPECIAL
• Status: Recruiting
• Phase: Phase 2
• First received: November 29, 2012
• Last updated: December 19, 2012
• Start date: September 2011
• Est. completion date: December 2016

Study information

• Verified date: December 2012
• Source: Zhejiang Cancer Hospital
• Contact: xiangdong Cheng, MD
• Phone: +86 571 88122516
• Email: abdsurg[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Safety
• Surgically-Created Resection Cavity

Intervention

Drug:
• S-1 + Paclitaxel Chemotherapy
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

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radical resection rate	radical resection rate	3 months	Yes
Secondary	Adverse Events	Number and degree of Adverse Events	6 months	Yes
Secondary	reaction rate	the reaction rate of chemotherapy	2 months	No
Secondary	overall survival time	the overall survival time	3 years	Yes