Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer
Conditions
Surgically-Created Resection Cavity - Drug Safety
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1 + Paclitaxel Chemotherapy
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: xiangdong Cheng, MD - +86 571 88122516 - abdsurg@hotmail.com
Start Date
September 2011
Completion Date
December 2016
Sponsors
Zhejiang Cancer Hospital
Source
Zhejiang Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page