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

NCT01756183 | Unknown Phase 2 DMC

• 1 other identifier: SPECIAL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgically-Created Resection Cavity; Drug Safety

Outcome Measures

Primary Outcomes (1)

• radical resection rate

  radical resection rate

  3 months

Secondary Outcomes (3)

• Adverse Events

  6 months

• reaction rate

  2 months

• overall survival time

  3 years

Study Arms (1)

S-1 + Paclitaxel Chemotherapy

EXPERIMENTAL

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

Interventions

S-1 + Paclitaxel Chemotherapy DRUG

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

S-1 + Paclitaxel Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

S 1 (combination)

Study Officials

• xiangdong Cheng, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiangdong Cheng, MD

CONTACT

+86 571 88122516; abdsurg@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 25, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2016
• Last Updated: December 25, 2012

Record last verified: 2012-12

Locations

CN (1)