JRCT ID: jRCTs051180012
Registered date:04/12/2018
NSOX study
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Gastric cancer with peritoneal metastasis |
Date of first enrollment | 21/05/2018 |
Target sample size | 59 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | 1. Nab-Paclitaxel:50-80 mg/m2 on days 1 and 8 2. Oxaliplatin: 100 mg/m2 on day 1 3. S-1:40mg/m2 bid (80mg/m2/day) between day 1 and 14 Patients receive five courses of No.1,2,3 therapies. |
Outcome(s)
Primary Outcome | Phase I: Rate of dose limiting toxicity (DLT) Phase II: Rate of negative conversion in peritoneal dissemination |
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Secondary Outcome | Phase I:adverse events 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 |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 75age old |
Gender | Both |
Include criteria | 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 |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Nakamura Masaki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000030909 |
Contact
Public contact | |
Name | Masaki Nakamura |
Address | 811-1 Kimiidera,Wakayama-shi,Wakayama, Japan Wakayama Japan 641-8510 |
Telephone | +81-73-441-0613 |
twins@wakayama-med.ac.jp | |
Affiliation | Wakayama Medical University Hospital |
Scientific contact | |
Name | Masaki Nakamura |
Address | 811-1 Kimiidera,Wakayama-shi,Wakayama, Japan Wakayama Japan 641-8510 |
Telephone | +81-73-441-0613 |
twins@wakayama-med.ac.jp | |
Affiliation | Wakayama Medical University Hospital |