JCOG2101C: Preoperative therapy of GS vs. GnP randomized trial for resectable pancreatic cancer in geriatric patients

Phase 3

Recruiting

Conditions: resectable pancreatic cancer

Registration Number: JPRN-jRCTs031220351

Lead Sponsor: O Michiaki

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 400

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) Age, 70 - 79 years.
(5) ECOG performance status, 0 or 1.
(6) No Grade 2 or greater peripheral sensory neuropathy or peripheral motor neuropathy.
(7) Sufficient oral intake
(8) No watery stool.
(9) No previous chemotherapy, radiotherapy, immunotherapy, or surgery for pancreatic cancer (treatment of jaundice and staging laparoscopy are acceptable).
(10) Peritoneal lavage cytology is negative if staging laparoscopy or percutaneous peritoneal lavage is performed before enrollment.
(11) No sign of ischemia on latest ECG.
(12) No dementia, or dementia with family support to continue protocol treatment or examinations
(13) Adequate function of major organs.
(14) Written informed consent.

Exclusion Criteria

(1) Synchronous or metachronous (within 5 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.
(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 either one of flucytosine, phenytoin, or warfarin.
(11) Allergy to iodine.
(12) History of severe hypersensitivity to nab-paclitaxel.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Progression-free survival, response rate of neoadjuvant chemotherapy, pathological response rate, proportion of no resection, proportion of R0 resection, incidence of adverse events, proportion of non-IADL decline