NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051180012

Registered date:04/12/2018

NSOX study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedGastric cancer with peritoneal metastasis
Date of first enrollment21/05/2018
Target sample size59
Countries of recruitment
Study typeInterventional
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 OutcomePhase I: Rate of dose limiting toxicity (DLT) Phase II: Rate of negative conversion in peritoneal dissemination
Secondary OutcomePhase 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
Age maximum<= 75age old
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Masaki Nakamura
Address 811-1 Kimiidera,Wakayama-shi,Wakayama, Japan Wakayama Japan 641-8510
Telephone +81-73-441-0613
E-mail 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
E-mail twins@wakayama-med.ac.jp
Affiliation Wakayama Medical University Hospital