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

JRCT ID: jRCTs031220351

Registered date:01/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: resectable pancreatic cancer
• Date of first enrollment: 05/01/2023
• Target sample size: 400
• Study type: Interventional

Intervention(s)

Arm A: Neoadjuvant chemotherapy with gemcitabine (1,000 mg/m2, IV, day 1, 8) plus S-1 (80-120 mg/day, p.o., day 1-14) followed by surgery and adjuvant chemotherapy with S-1 (80-120 mg/day, p.o., day 1-28)
Arm B: Neoadjuvant chemotherapy with gemcitabine (1,000 mg/m2, IV, day 1, 8) plus nab-paclitaxel (125 mg/m2 day 1, 8, 15) followed by surgery and adjuvant chemotherapy with S-1 (80-120 mg/day, p.o., day 1-28)

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: <= 79age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: UNNO Michiaki
• Secondary Sponsor: TAIHO PHARMACEUTICAL CO., LTD.
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development