MedDataX Logo

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

NCT ID: NCT01756183

Last Updated: 2012-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgically-Created Resection Cavity Drug Safety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

S-1 + Paclitaxel Chemotherapy

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

xiangdong Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

xiangdong Cheng, MD

Role: CONTACT

Phone: +86 571 88122516

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

xiangdong Cheng, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SPECIAL

Identifier Type: -

Identifier Source: org_study_id