Actively Recruiting
A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 for Unresectable Locally Advanced or Lymph Node-Metastatic Gastric Cancer
Led by Asan Medical Center · Updated on 2026-04-07
63
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastric cancer is a common and deadly cancer worldwide, particularly in Korea, where it is a leading cause of cancer death. Surgery to remove the cancer completely is the main cure, but many patients cannot have this due to local spread or distant lymph node involvement. This research evaluates a combination chemotherapy before surgery, called neoadjuvant chemotherapy, to improve outcomes by shrinking tumors, treating early spread, and avoiding unnecessary surgeries in patients with advanced or metastatic gastric cancer limited to lymph nodes. The trial studies the use of three chemotherapy drugs: docetaxel and oxaliplatin given intravenously every three weeks, and S-1 taken orally twice daily for two weeks, repeated in cycles. This treatment is given before surgery in patients whose cancers are locally advanced or have distant metastases limited to lymph nodes, aiming to improve the rate of complete tumor removal (R0 resection). The study is a phase 2 clinical trial assessing safety and effectiveness of this chemotherapy combination in this patient group. Participants will be monitored for tumor removal success one year after chemotherapy. Throughout the trial, patients will undergo physical exams, imaging scans, laboratory tests, and assessments of organ function to track treatment safety and cancer response. Researchers also measure survival times and biological markers. The study includes careful follow-up to evaluate treatment outcomes and side effects, with total participation lasting through preoperative chemotherapy and at least one year for surgery outcomes.
CONDITIONS
Brief Title
A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic gastric adenocarcinoma
- CT-proven invasion of surrounding organs (T4) or limited distant lymph node metastasis with specific size and features
- Age 19 years or older
- Life expectancy of at least 3 months
- ECOG performance status of 0 or 1
- Adequate normal organ and bone marrow function as defined by specific lab values
- No previous chemotherapy or radiation therapy
- Ability to comply with study follow-up requirements
- Evidence of menopause or negative pregnancy test in premenopausal women
- Ability to provide written informed consent
You will not qualify if you...
- Pregnant or lactating women or those not using appropriate contraception
- Non-adenocarcinoma cancers
- Distant metastasis beyond lymph nodes or ascites on abdominal CT
- History of other active cancers except certain skin or cervical cancers
- Central nervous system metastasis
- Clinically significant intestinal obstruction or gastrointestinal bleeding
- History of organ transplantation
- Active infections like tuberculosis, hepatitis B or C, or HIV as defined by tests
- Average QTcF interval over 470 ms on ECG
- Serious medical conditions including unstable heart disease, recent myocardial infarction, neurological or psychiatric diseases, active infections, severe diarrhea, high calcium levels not controlled by treatment, or active intravascular coagulation
- Use of corticosteroids beyond allowed doses
- Concurrent participation in other clinical trials or treatments such as chemotherapy, hormone therapy, or immunotherapy
- Other conditions judged inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until completion of planned chemotherapy
Participants receive neoadjuvant chemotherapy consisting of intravenous docetaxel and oxaliplatin every 3 weeks and oral S-1 twice daily for 14 days as part of the treatment regimen.
1 visit every 3 weeks for intravenous administration and assessments
Trial Site Locations
Total: 1 location
1
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Seoul, South Korea, 138-736
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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