Tokyo, Nov. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059851) titled 'Phase II study to evaluate Extensive intraoperative peritoneal lavage (EIPL) for gastric cancer patients with positive cytology either by peritoneal lavage stamp method' on Nov. 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Osaka City University

Condition: Condition - Gastric Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy of extensive lavage regarding recurrence free survival for patients with positive cytology either by extensive lavage or stamp method who during gastrectomy with D2 lymph node dissection. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - extensive intra-peritoneal lavage for patients with CY or Stamp positve

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Histologically diagnosed with gastric cancer (pap, tub1, tub2, por1, por2, sig, muc, or a special type) based on endoscopic biopsy from the primary gastric lesion. Positive peritoneal lavage cytology or gastric wall imprint cytology, but no evidence of distant metastasis; eligible for R0/1 resection via gastrectomy with D2 lymph node dissection (including total or distal gastrectomy, and laparoscopic surgery). General anesthesia combined with epidural anesthesia will be used. Esophageal invasion is within 3 cm and no thoracotomy has been performed. Aged between 20 and 80 years. Performance Status (ECOG) of 0 or 1. No prior history of chemotherapy (including endocrine therapy) or radiotherapy, including for other malignancies. Meets all of the following laboratory criteria (based on the most recent preoperative test results within 56 days prior to enrollment; tests conducted on the same weekday up to 8 weeks before enrollment are acceptable): Data regarding WBC, Plt, AST, ALT, T-Bil, and Cre Written informed consent for participation in the study has been obtained from the patient. Key exclusion criteria - Women who are pregnant or breastfeeding, or who may be pregnant. Individuals with psychiatric disorders or symptoms deemed unable to participate in the study. Individuals receiving continuous systemic administration of steroids (oral or intravenous). Individuals with a history of myocardial infarction within the past six months or with unstable angina. Individuals with uncontrolled hypertension. Individuals undergoing insulin therapy or with uncontrolled diabetes. Individuals with respiratory diseases requiring continuous oxygen therapy. Target Size - 65

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2016 Year 12 Month 28 Day Date of IRB - 2017 Year 03 Month 07 Day Anticipated trial start date - 2017 Year 04 Month 01 Day Last follow-up date - 2024 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068445

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