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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00587145
• Other study ID #: NCCCTS-06-190
• Secondary ID: 82-31-920-1609
• Status: Recruiting
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: December 21, 2007
• Start date: May 2006
• Est. completion date: May 2009

Study information

• Verified date: December 2007
• Source: National Cancer Center, Korea
• Contact: Sook Ryun Park, M.D
• Phone: +82-31-920-1609
• Email: sukryun73[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Korea	Goyang,	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the clinical responses to preoperative S-1 plus docetaxel		During chemotherapy	No
Secondary	the clinical downstaging,the pathologic responses, toxicity profile,the disease-free survival,overall survival,the effect of CYP2A6 genetic polymorphisms on the pharmacokinetics and the difference in pharmacokinetics between before and after gastrectomy		During study period	Yes