JPRN-jRCTs041230019
Recruiting
Phase 2
A Multicenter phase II study to investigate the efficacy of systemic chemotherapy in patients with peritoneal WAshing cytoLogy-positive potentially CUrable pancREatic cancer (WALCURE trial) - WALCURE trial
Tsutomu Fujii0 sites208 target enrollmentMay 18, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Patients who diagnosed pancreatic cancer with positive for peritoneal washing cytology
- Sponsor
- Tsutomu Fujii
- Enrollment
- 208
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(i) Patients with histologically\- or cytologically\-confirmed adenocarcinoma of the pancreas
- •(ii) Patients with a diagnosis of primary resectable or borderline resectable (BR\-PV and BR\-A) pancreatic cancer at enrollment (General Rules for the Study of Pancreatic Cancer, the 7th edition) who tested positive for peritoneal washing cytology during staging laparoscopy or laparotomy before the start of treatment
- •(iii) Patients aged 20 years or older at enrollment
- •(iv)Patients with a PS of 0 to 1
- •(v)Patients who have not received prior treatment (such as radiotherapy, chemotherapy, and immunotherapy) for the underlying disease
- •(vi)Patients who have adequate major organ function
- •White blood cells: 12,000 /mm3 or less
- •Neutrophils: 1,500 /mm3 or more
- •Hemoglobin levels: 9\.0 g/dL or more
- •Platelets: 100,000 /mm3 or more
Exclusion Criteria
- •(i) Patients who have received prior treatment (such as radiotherapy, chemotherapy, and immunotherapy) for the underlying disease
- •(ii) Patients with primary unresectable pancreatic lesions
- •(iii) Patients who underwent resection of the primary tumor
- •(iv) Patients with peritoneal metastatic nodules or those with metastatic lesions, such as lymph nodes, other than the liver, lung, bone, or regional lymph nodes
- •(v) Patients with contraindications or known history of severe hypersensitivity or infusion related reactions to gemcitabine, nab\-paclitaxel/paclitaxel, liposomal irinotecan, leucovorin, or fluorouracil and to any of the excipients
- •(vi) Patients with known infection or inflammation at study enrollment (including those who have a fever of 38 degrees celsius or higher)
- •(vii) Patients with serious (hospitalization needed) complications (such as heart disease, intestinal paralysis, ileus, confirmed diagnosis of interstitial lung disease, difficult\-to\-control diabetes, renal failure, and hepatic cirrhosis)
- •(viii) Patients with excessive ascites or pleural effusion
- •(ix) Patients receiving atazanavir hydrochloride
- •(x) Patients with fresh gastrointestinal bleeding requiring repeated blood transfusions
Outcomes
Primary Outcomes
Not specified
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