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

Phase 2

• Conditions: Surgically-Created Resection Cavity; Drug Safety
• Interventions: Drug: S-1 + Paclitaxel Chemotherapy

• Registration Number: NCT01756183
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-11-29
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-19
• Last Update Submitted: 2012-12-19
• Study First Posted: 2012-12-25
• Last Update Posted: 2012-12-25
• Primary Completion: 2013-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-1 + Paclitaxel Chemotherapy	S-1 + Paclitaxel Chemotherapy	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

Primary Outcome Measures

Name	Time	Method
radical resection rate	3 months	radical resection rate

Secondary Outcome Measures

Name	Time	Method
Adverse Events	6 months	Number and degree of Adverse Events
reaction rate	2 months	the reaction rate of chemotherapy
overall survival time	3 years	the overall survival time

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China