Resectable pancreatic cancer
Conditions
Interventions
Arm A: Two courses of neoadjuvant chemotherapy with gemcitabine (1,000 mg/m2, IV, days 1, 8) plus S-1 (80-120 mg/day, p.o., days 1-14) followed by surgery and four courses of adjuvant chemotherapy wit
Sponsors
IKEDA Masafumi
KAMEI Keiko
MATSUMOTO Ippei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically proven pancreatic carcinoma meeting either one of the following conditions in primary tumor. (i) Histologically proven invasive ductal carcinoma; adenocarcinoma (well differentiated type, moderately differentiated type, or poorly differentiated adenocarcinoma) or adenosquamous carcinoma (ii) Cytologically proven Class IV or Class V and it is radiologically diagnosed to be compatible with invasive ductal carcinoma (2) Resectable pancreatic cancer by chest computed tomography (CT) and enhanced abdominal/pelvic CT. (3) Open surgery is scheduled for pancreatic cancer. (4) No previous chemotherapy, radiotherapy, immunotherapy, or surgery for pancreatic cancer (treatment of jaundice, staging laparoscopy, and percutaneous peritoneal lavageare acceptable). (5) Peritoneal lavage cytology is negative if staging laparoscopy or percutaneous peritoneal lavage is performed before enrollment. (6) Age, 18 - 75 years. (7) ECOG performance status, 0 or 1. (8) No Grade 2 or greater peripheral sensory neuropathy or peripheral motor neuropathy. (9) Sufficient oral intake (10) No watery stool. (11) Sufficient organ function (assessed within 14 days prior to registration): (i) Neutrophil count >=1,500/mm3 (ii) Hemoglobin >=9.0 g/dL, without blood transfusion within 14 days of blood test (iii) Platelet count >=100,000/mm3 (iv) Serum albumin >=3.0 g/dL (v) Total bilirubin =50 mL/min (12) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Synchronous or metachronous (within 2 years) malignancies. (2) Infectious disease requiring systemic treatment (excluding hepatitis viral). (3) Pyrexia of 38 or higher degrees centigrade. (4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. (5) Severe psychological disorders. (6) Receiving continuous systemic corticosteroid or immunosuppressants, except systemic administration of up to 10 mg/day of prednisolone equivalent. (7) Severe comorbidities (such as heart failure, renal failure, hepatic failure, paresis of intestine, ileus, poorly controlled diabetes, or poorly controlled hypertension). (8) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT. (9) History of unstable angina pectoris with new onset or exacerbation within recent 3 weeks or myocardial infarction within 6 months before registration. (10) Requiring continuous administration of flucytosine, phenytoin, or warfarin. (11) Allergy to iodine. (12) History of severe hypersensitivity to nanoliposomal irinotecan, oxaliplatin, gemcitabine, or S-1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety run-in part: adverse events during preoperative NASOX, intraoperative complications, postoperative complications (within 30 days after surgery) Phase II part: completion of perioperative NASOX Phase III part: overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II part: response rate of neoadjuvant chemotherapy, pathological response rate, incidence of adverse events, incidence of serious adverse events Phase III part: progression-free survival, response rate of neoadjuvant chemotherapy, proportion of R0 resection, pathological response rate, completion of protocol treatment, incidence of adverse events, incidence of serious adverse events, incidence of surgical complications | — |
Contacts
Public ContactMitsuhito SASAKI
National Cancer Center Hospital East
Outcome results
None listed