colorectal cancer with peritoneal metastasis
Conditions
Interventions
20mg/m2 of weekly Intraperitoneal paclitaxel
Sponsors
The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The cases of primary or recurrent colorectal cancer which are histologically confirmed as adenocarcinoma. (The cases of appendiceal carcinoma and anal canal cancer are excluded.) 2) Peritoneal carcinomatosis is detected or suspected. 3) The cases without uncontrollable distant metastases. 4) The cases within 2 months from the beginning of surgery or chemotherapy for peritoneal carcinomatosis. 5) The cases which meet criteria as follows: 1. The number of white blood cells: More than lower limit of standard value and less than 12,000/mm3 2. The number of neutrophil: More than 1,500/mm3 3. The amount of hemoglobin: More than 8.0 g/dl 4. The number of platelet: More than 100,000/mm3 5. AST/ALT: Less than 100 U/L 6. Total bilirubin: Less than 1.5 times as much as upper limit of standard value. 7. eGFR: More than eGFR: 60 mL/min/1.73m2 6) Performance Status (ECOG scale): 0-1 7) Informed consent is obtained.
Exclusion criteria
Exclusion criteria: 1) The patients who have another cancer in the time of entry. 2) The patients who have large amount of ascites which requires drainage more than three times per week. 3) Postoperative chemotherapy including oxaliplatin was performed within 1 year. 4) The cases with contraindication of fluorouracil, levofolinate calcium, capecitabine, oxaliplatin, bevacizumab, or paclitaxel. 5) The patients with brain tumors or brain metastases. 6) The patients with infectious diseases. 7) The patients with thrombotic diseases or embolic diseases within one year. 8) The patients requiring anticoagulant drug. 9) PT-INR>1.5 or tendency to bleed. 10) The patients who are pregnant. 11) Attending doctor decided the patients are unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| One year survival rate, progression free survival, response rate, the rate of improvement of peritoneal cancer index, the rate of negative conversion of the cytology of peritoneal lavage | — |
Countries
Japan
Contacts
Public ContactKoji Murono
The University of Tokyo Department of Surgical Oncology and Vascular Surgery
Outcome results
None listed