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)
WALCURE trial (WALCURE trial)
Tsutomu Fujii
University of Toyama
2630, Sugitani, Toyama 930-0194 Japan
+81-76-434-7331
fjt@med.u-toyama.ac.jp
Kazuto Shibuya
University of Toyama
2630, Sugitani, Toyama 930-0194 Japan
+81-76-434-7331
shibuyak@med.u-toyama.ac.jp
Recruiting
June. 01, 2023
208
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
(i) Patients with histologically- or cytologically-confirmed adenocarcinoma or adenosquamous carcinoma 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
Total bilirubin: less than 2.0 mg/dL (3.0 mg/dL or less in patients who underwent biliary drainage)
Creatinine: 1.5 mg/dL or less
AST and ALT: 2.5 multiplied by the upper limit of the institutional normal range
(vii) Patients who have received less than one month of prior chemotherapy and who have not had apparent tumor progression or serious adverse events since the start of treatment.
(viii) Patients who have provided consent to participate in this study
(i) Patients who have received prior treatment (such as radiotherapy, chemotherapy, and immunotherapy) for the underlying disease (However, patients who have had less than one month of prior chemotherapy and who have not had apparent tumor progression or serious adverse events since the start of treatment are acceptable for enrolment.)
(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
(xi) Patients with diarrhea (4 times or more a day or watery stool)
(xii) Patients who are receiving antipsychotic treatment or have psychiatric disorder potentially requiring treatment and are unable to understand an explanation
(xiii) Patients with synchronous double cancer at enrollment
Patients with synchronous multiple cancers or metachronous multiple cancers with a disease-free interval of 2 years or less. However, cancers with a 5-year relative survival rate of 95% or higher are excluded from the exclusion criteria, even if the disease-free interval is less than 2 years.
To be specific, the following are excluded:
(In general, each staging should be based on UICC-TNM 7th edition or equivalent Japanese classification of cancers.)
a)Clinical stage I prostate cancer
b)Clinical stage 0 or I laryngeal cancer in which complete response was achieved by radiotherapy
c)Completely resected cancer with the following pathologic staging:
Gastric cancer (adenocarcinoma), Stages 0 to I; colorectal cancer (adenocarcinoma), Stages 0 to I;
esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma), Stage 0;
breast cancer (ductal carcinoma in situ or lobular carcinoma in situ), Stage 0;
breast cancer (infiltrating duct carcinoma, infiltrating lobular carcinoma, or Paget's disease), Stages 0 to IIA;
endometrial cancer (endometrioid adenocarcinoma or mucinous adenocarcinoma), Stage I; prostate cancer (adenocarcinoma), Stages I to II;
cervical cancer (adenosquamous carcinoma), Stage 0; thyroid cancer (papillary carcinoma or follicular carcinoma), Stages I to III;
kidney cancer (clear cell carcinoma or chromophobe cell carcinoma), Stage I;
other lesions equivalent to intramucosal carcinoma
(xiv) Pregnant women or nursing mothers and women of child-bearing potential (who wish to become pregnant)
(xv) Patients who may have difficulty providing effective informed consent
20age old over
No limit
Both
Patients who diagnosed pancreatic cancer with positive for peritoneal washing cytology
Chemotherapy for Pancreatic Cancer with peritoneal washing cytology
1st line: Gemcitabine hydrochloride (GEM) and nab-paclitaxel
2nd line: liposomal irinotecan plus 5-FU/LV
pancreatic cancer, peritoneal washing cytology
Overall survival in resectable (R) pancreatic cancer (calculated from the first day of first-line chemotherapy)
For borderline resectable (BR) pancreatic cancer,
a) Overall survival, progression free survival, (calculated from the first day of first-line chemotherapy), overall survival, progression free survival, (calculated from the first day of second-line chemotherapy), adverse events, response rate, disease control rate, progression-free survival, and CY negative conversion rate in the first-line treatment;
b) CY negative conversion rate in the second-line treatment and overall survival, CY negative conversion rate, adverse events, response rate, and disease control rate by reason why the patient underwent second- or subsequent-line treatment (disease progression during the first-line treatment vs intolerance due to adverse events in the first-line treatment);
c) CY negative conversion rate in third- or subsequent-line treatment; and
d) CY negative conversion rate in all treatments, number of chemotherapy regimens until CY negative conversion, rate of conversion surgery performed, and percentage decrease in tumor markers in each regimen.
NIHON SERVIER
Clinical Research Review Board, University of Toyama
