JPRN-jRCTs071180001Active, not recruitingPhase 2
Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced gastric adenocarcinoma in elderly patients - KSCC1801
Saeki Hiroshi0 sites25 target enrollmentStarted: June 27, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 70age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1)The individual consents in writing to receipt of the protocol treatment.
- •2)The cancer is histologically confirmed (via biopsied tissue) to be an adenocarcinoma.
- •3)The tumor is diagnosed with cT3-4 by imaging findings.
- •4)Enhanced upper abdominal CT revealed having gastric regional lymph nodes swelling with greater than 8mm in minor axis diameter or 10mm in major axis diameter (N1-3).
- •5)Enhanced thoracic/ abdominal/ pelvic CT revealed having none of the followings:
- •i) Lung metastasis
- •ii) Peritoneal metastasis
- •iii) Liver metastasis
- •iv) Pleural effusion, ascites
- •v) Distal lymph nodes metastasis
- •vi) Other distant metastasis
- •6) Clinically no sign of cervical lymph node nor distant metastasis.
- •7) No liver metastasis and peritoneal metastasis, CY0 by laparoscopy.
- •8) Not a remnant gastric cancer.
- •9) The patient can have oral intake.
- •10) No prior chemotherapy or radiation therapy or endocrine therapy against any other malignancies within 5 years.
- •11) 70 years of age or older
- •12) Performance Status (ECOG) 0 or 1
- •13) The patient's laboratory results from up to 14 days prior to enrollment fall within the criteria
- •i) Neutrophil >=1,500/mm3
- •ii) Hemoglobin >=8.0g/dL
- •iii) Platelet >=100,000/mm3
- •iv) Total bilirubin <=1.5mg/dL
- •v) AST <=100IU/L
- •vi) ALT <=100IU/L
- •vii) Creatinine clearance >=40mL/min
Exclusion Criteria
- •1) 3cm or greater in distance of esophageal invasion
- •2) Type 4 gastric cancer macroscopically involving whole stomach
- •3) Severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1)
- •4) Peripheral neuropathy affecting the sensory nerves (Grade 1 or worse)
- •5) Active infection
- •6) Uncontrollable hypertension
- •7) Uncontrollable diabetes mellitus
- •8) Heart disease that may pose a problem
- •9) Severe pulmonary disease
- •10) Severe mental disease
- •11) Active gastrointestinal tract bleeding requiring repeated transfusions
- •12) Under treatment with phenytoin, warfarin or flucytosine
- •13) Watery diarrhea (Grade 2 or worse)
- •14) Synchronous or metachronous active malignancies
- •15) A man who is trying to conceive with a partner
- •16) Cirrhosis or active hepatitis
- •17) Patients judged by the investigator as unfit to be enrolled in the study.
Investigators
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