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New treatment option for Stomach Neoplasm
Official 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
ClinicalTrials.gov ID: NCT05184803
What this study is testing
What is Docetaxel injection, oxaliplatin, S-1?
Docetaxel injection, oxaliplatin, S-1 is an investigational medicine, given as a twice-daily injection under the skin, being studied as a potential treatment for stomach neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Gastric cancer is the fifth most common carcinoma in the world, and cancer-related deaths rank third. It is one of the main causes of death from cancer in Korea.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Histologically or cytologically proven metastatic gastric adenocarcinoma patients
- As a patient who has been proven by CT to have invasion of surrounding organs (T4) according to the 8th edition of the American Joint Commission...
- Over 18 years old.
- Patients with a life expectancy of at least 3 months.
- Patients with 0 or 1 ECOG performance status
You likely can't join if
- When pregnant women, lactating women, or pregnant women do not use appropriate contraception methods.
- Cancer other than adenocarcinoma.
- Patients with distant metastasis other than lymph nodes or confirmed ascites on abdominal CT before surgery.
- History of other carcinomas or presence of pathogenic cancer (excluding non-melanoma skin cancer or cervical epithelial cancer)
- Central nervous system metastasis.
- Clinically significant intestinal obstruction or gastrointestinal bleeding.
See the full eligibility criteria
- Histologically or cytologically proven metastatic gastric adenocarcinoma patients
- As a patient who has been proven by CT to have invasion of surrounding organs (T4) according to the 8th edition of the American Joint Commission (AJCC) or confined to remote lymph nodes, the criteria for lymph node...
- Over 18 years old.
- Patients with a life expectancy of at least 3 months.
- Patients with 0 or 1 ECOG performance status
- As defined in the relevant items below, those who have confirmed appropriate normal organ and bone marrow function:
- Haemoglobin 9 9.0 g/dL.
- Absolute neutrophil count (ANC) \> 1.5 x 103/mCL (\> 1,500 per mm3)
- Platelet count 100 100 x 109/L
- Serum bilirubin 1.5 1.5 x Test Laboratory Upper Limit of Normal (ULN).
- AST(SGOT)/ALT(SGPT) 2.5 2.5x ULN of test institution.
- Measured creatinine clearance (CL) \> 40 mL/min or Cockcroft-Gault formula (Cockcroft and Gault 1976) calculated by or according to 24-hour urine samples for determining creatinine cleaning rates.
- Male creatinine CL (mL/min) = Weight (kg)x (140-age) / 72x Serum creatinine (mg/dL)
- Women's creatinine CL (mL/min) = Weight (kg)x (140-age) / 72 x Serum creatinine (mg/dL) x 0.85
- A patient who has never had chemotherapy before.
- Patients who have not previously had radiation therapy experience
- Physical, family, social, and geographic conditions for the follow-up of patient conditions required for this study should be free of obstacles in this study.
- Evidence of menopause or negative findings of urine or blood pregnancy response should be confirmed in premenopausal women. Women who are premenstrual for more than 12 months without any other medical cause are...
- people who can provide signed consent, such as compliance with the requirements and taboos specified in the test subject's consent (ICF) and this plan. Written consent must be obtained from the patient and the patient's...
- When pregnant women, lactating women, or pregnant women do not use appropriate contraception methods.
- Cancer other than adenocarcinoma.
- Patients with distant metastasis other than lymph nodes or confirmed ascites on abdominal CT before surgery.
- History of other carcinomas or presence of pathogenic cancer (excluding non-melanoma skin cancer or cervical epithelial cancer)
- Central nervous system metastasis.
- Clinically significant intestinal obstruction or gastrointestinal bleeding.
- A patient with a history of organ transplantation.
- Active infections such as tuberculosis, hepatitis B, hepatitis C, or HIV identified by TB tests according to medical history, physical examination, radiological findings, and regional standards.
- Tuberculosis: Tuberculosis confirmed by medical history, physical examination, or radiologically active tuberculosis, and tuberculosis tests according to regional standards (excluding active TB, old TB is acceptable)
- Hepatitis B: If HBsAg is negative, register, and if HBsAg is positive, HBV DNA test is performed.
- HBV DNA 500 500iu/ml (or 2500 copies/ml): Excluded
- HBV DNA ▶500iu/ml (or 2500 copies/ml): Allow
- Hepatitis C: If HCV Ab is negative, register, and if HCV Ab is positive, HCV RNA test is performed.
- If HCV RNA is positive, I'll exclude it.
- If it's HCV RNA's voice, it's allowed.
- HIV: HIV Ag/Ab : excluding reactive faces, HIV Ag/Ab : non-reactive faces registration
- Average QTcF (average QT interval for heart rate correction using fridericia formula) \> 470 ms when calculated with three ECG tests (within 15 minutes at 2-5 minute intervals). If -1 test is performed and QTcF \> 470...
- Other serious diseases or medical conditions.
- Uncurable unstable heart disease, myocardial infarction within 6 months before the start of the study.
- A history of neurological or psychiatric diseases including dementia or seizures.
- Active, non-regulatory infection.
- Clinically serious diarrhea.
- Severe high calcium conditions above 12 mg/dL, which are not controlled by phonates.
- Other serious medical conditions that may affect participation in this study.
- Active random intravascular coagulation.
- Patients who other researchers find inappropriate.
- In the case of recent corticosteroids (or corresponding) treatment, except for acute hypersensitivity response therapy or low-dose (\<20 mg methylprednisolone or corresponding) chronic treatment (started 6 months before...
- In addition to the test drug, administration of other clinical research drugs within 4 weeks or in combination.
- Combination chemotherapy, hormone therapy, or immunotherapy.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.