SOX study
- Conditions
- Gastric cancer with peritoneal metastasis
- Registration Number
- JPRN-jRCTs051180012
- Lead Sponsor
- akamura Masaki
- Brief Summary
The NSOX regimen was shown to be a tolerable regimen and may be a promising triplet therapy for patients with gastric cancer with peritoneal metastasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
1. Histologically proven adenocarcinoma of gastric cancer and positive peritoneal dissemination by staging laparoscopy (except recurrent gastric cancer )
2. HER2 negative (or untested)
3. No non-curative factors except for peritoneal dissemination
4. No prior chemotherapy or radiation therapy (in case of previous adjuvant therapy, interval between end of chemotherapy and relapse must be > 6 months for S-1 therapy)
5. Age 20-75 years
6. ECOG PS 0 or 1
7. Able to ingest
8. Patients must have normal organ and marrow function as defined below within 14 days prior to enrollment :
Neutrophils (ANC) >= 1,500 /mm3
Platelets >=100,000 /mm3
Hemoglobin >= 8g/dL
Serum bilirubin <= 2.0 x upper normal limit (ULN)
AST/ALT <= 100 U/L
Serum creatinine level <= 1.2 mg/dL
CCR >= 60 mL/min
9. Life expectancy of at least 3 months
10.Signed and dated informed consent
1. History of hypersensitivity to nab-paclitaxel, S-1 or oxaliplatin
2. Contraindication for nab-paclitaxel, S-1 or oxaliplatin
(e.g. cases receiving severe bone marrow function suppression, severe renal disorder, severe liver disorder, administration of other pyrimidine-based antitumor agents, fluoride or flucytosine)
3. Active infectious disease
4. HBs-antigen positive
5. Severe complications, such as those listed below:
Uncontrolled heart failure/unstable angina pectoris/cardiac arrhythmia
Myocardial infarction (< 3 months prior to study entry)
Uncontrolled diabetes mellitus, uncontrolled hypertension
Interstitial pneumonia, pulmonary fibrosis
Complications that present serious obstacles to this study
6. Symptomatic neuropathy
7. Known brain metastasis with clinical symptoms
(if asymptomatic, examination is not required)
8. Watery diarrhea.
9. Active double cancer.
Synchronous or metachronous(within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy
10. Breast-feeding, pregnant or planning pregnancy
11. Patients who are otherwise judged to be ineligible for enrolment by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Rate of dose limiting toxicity (DLT)<br>Phase II: Rate of negative conversion in peritoneal dissemination
- Secondary Outcome Measures
Name Time Method Phase I:adverse events<br>Phase II:completion rate of chemotherapy, response rate, curative resection rate(R0 resection rate 0), rate of postoperative complications after the radical excision, pathological response rate , rate of adverse events, progression free survival, rate of disease control, relapse free survival after the radical excision, overall survival, time to treatment failure