gastric cancer with para-aortic lymph node metastasis
Conditions
Interventions
Preoperative chemotherapy with Docetalxel+CDDP+S-1 followed by gastrectomy with D2 and para-aortic nodal dissection
Sponsors
Digestive Disease Support Organization (DDSO)
1)Department of surgery, Toyama prefectural central hospital 2)1st Department of Surgery Faculty of Medicine University of Fukui 3)Department of surgery, Saiseikai Yahata general hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric carcinoma 2) Para-aortic lymph node metastassis which was more than 10mm in diameter by contrast enhanced CT 3) None of the liver metastasis and distal metastaisis outside the para-aortic region, as confirmed by contrast enhanced CT. No peritoneal dissemination and negative cytology at laparoscopic examination. 4) Macroscopic 0,1,2,3,5 (excpet for type 3 which is more than 8cm in diameter) 5) Primary tumor with >=3 cm esophageal invasion by clinical imagings 6) Age between 20 and 75 at registration 7) Performance Status(ECOG) 0 or 1 8) No prior chemotherapy or radiotherapy and no prior surgery for gastric carcinoma 9) No acute hemorrhage from primary tumor 10)Fair oral intake 11)blood test WBC >= 3,000/mm3 and <= 12,000/mm3 NEU >= 1,500/mm3 Hb >= 9.0 g/dl Platelet >= 100,000/mm3 GOT,GPT <= 100IU T.bil <= 2.0 mg/dl Creatinin <= 1.2mg/dl 24Ccr >= 60ml/min/body 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patient with clinically obvious infecton 2) Serious complications(cardiac disease, respiratory dysfunction, bleeding disorder, severe HT or DM) 3) Gastric remnant cancer 4) Synchronous or metachronous malignancy in other organs including 5-year disease-free survival 5) Gastric cancer wtih distant metastasis 6) Past history of drug allergy of docetaxel or CDDP or S-1 7,8) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage 9) Probable pregnancy, and the period of lactation 10)Not fit to the protocol treatment by the physicion's dicision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| histological response of para-aortic lymph node in preoperative chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of completion of treatment, proportion of curative resection, response rate(RECISTv.1.0), 3-year survival, proportion of toxicities, proportion of treatment related death | — |
Countries
Japan
Contacts
Public ContactJun Kinoshita, MD
Kanazawa University Hospital Gastroenterlogic surgery
Outcome results
None listed