Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer

NCT ID: NCT00587145

Last Updated: 2008-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-05-31

Brief Summary

This study is an open-label, single center, and a single arm phase II study to evaluate the clinical response and safety of perioperative S-1 plus docetaxel. Perioperative chemotherapy is composed of 3 cycles of preoperative S-1/docetaxel and 3 cycles of postoperative S-1/docetaxel.Chemotherapy regimen:

• S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
• Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

S-1,Docetaxel

• S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
• Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed localized gastric adenocarcinoma as defined by CT stage III and IV (M0) (but not N3, which is metastatic node in WHO TNM classification), according to Japanese TNM classification system

2. No distant metastatic disease in laparoscopy

3. Age: 18-70 years

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

5. Disease status must be that of measurable disease as defined by RECIST: Measurable lesions: lesions that can be accurately measured in at least one dimension by abdominal CT, if the longest diameter to be recorded is at least 10 mm with spiral CT

6. Adequate major organ function including the following: Hematopoietic function: WBC ³ 4,000/mm3, ANC ³ 1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin £ 1.5 mg/dl, AST/ALT levels £ 2.5 x UNLRenal function: serum creatinine £ 1.5 mg/dl

7. Patients should sign a written informed consent before study entry

Exclusion Criteria

1. CT Stage I, II, M1 or N3, which is metastatic node in WHO TNM classification, according to Japanese TNM classification system

2. Prior chemotherapy or radiotherapy

3. Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality

4. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy

5. Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix

6. Psychiatric disorder that would preclude compliance

7. Pregnant, nursing women or patients with reproductive potential without contraception

8. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

National Cancer Center, Korea

Principal Investigators

Sook Ryun Park, M.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sook Ryun Park, M.D

Role: CONTACT

sukryun73@ncc.re.kr

+82-31-920-1609

So Yun Park, MS

Role: CONTACT

tomongmong@naver.com

+82-31-920-2307

Facility Contacts

Sook Ryun Park, M.D

Role: primary

sukryun73@ncc.re.kr

+82-31-920-1609

So Yun Park, MS

Role: backup

tomongmong@naver.com

+82-31-920-2307

Other Identifiers

82-31-920-1609

Identifier Type: -

Identifier Source: secondary_id

NCCCTS-06-190

Identifier Type: -

Identifier Source: org_study_id