Intraperitoneal Docetaxel With Cisplatin and TS-ONE for Gastric Cancer With Peritoneal Carcinomatosis

Launched by THE UNIVERSITY OF HONG KONG · Dec 27, 2013

Keywords

ClinConnect Summary

Peritoneal carcinomatosis (PC) is common in advanced gastric cancer, and it carries a poor prognosis; the median survival time is 3 to 6 months. Gastric cancer with PC is considered incurable and patients are subjected to non-surgical treatment, mainly chemotherapy. Currently, there is no established standard treatment for these patients.

Multidisciplinary approach to the treatment of gastric cancer including chemotherapy, radiotherapy and surgery has been developed and survival benefit has been demonstrated in the adjuvant setting. Novel chemotherapeutic agents: taxanes (paclitaxel and do...

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Eligibility criteria

• Inclusion Criteria:
• • Age≥18
• • Histologic confirmation of gastric adenocarcinoma
• • Positive peritoneal cytology or histological proven PC
• • Absence of other distant metastases except peritoneum and lymph node(s)
• * Adequate bone marrow and organ functions as defined below:
• • Leucocyte ≥3.00 x 109/L
• • Absolute neutrophil counts ≥ 1.50 x 109/L
• • Platelet ≥ 100 x 109/L
• • Total bilirubin ≤2 x ULN
• • AST/ALT ≤2.5 x ULN
• • Creatinine clearance ≥60ml/min
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• • Subjects of child-bearing potential must agree to contraception from screening to 6 months after completion of treatment
• • Provision of written informed consent
• Exclusion Criteria:
• • Any prior anti-cancer therapy for gastric cancer
• • Previous exposure to taxane, fluoropyrimidine or platinum chemotherapy
• • Previous radiotherapy to abdomen or pelvic region
• • Known hypersensitivity to study medication
• • Known dihydropyrimidine dehydrogenase (DPD) deficiency
• • Any prior or synchronous malignancy, except,
• • Malignancy treated with curative intent and with no evidence of disease for ≥5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician
• • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• • Subject is pregnant or breast feeding
• • Any serious concomitant illness