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

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

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

Study Overview

• Status: Unknown
• Conditions: Drug Safety; Surgically-Created Resection Cavity
• Intervention / Treatment: Drug: S-1 + Paclitaxel Chemotherapy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: xiangdong Cheng, MD; Phone Number: +86 571 88122516; Email: abdsurg@hotmail.com
      • Principal Investigator: Xiangdong Cheng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number and degree of Adverse Events	6 months
reaction rate	the reaction rate of chemotherapy	2 months
overall survival time	the overall survival time	3 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: December 19, 2012
• First Posted (ESTIMATE): December 25, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 25, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: SPECIAL