Neoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer; A phase II multicenter trial

JRCT ID: jRCT1011180032

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic ductal adenocarcinoma
• Date of first enrollment: 27/03/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Preoperative chemotherapy, surgery, postoperative chemotherapy

Outcome(s)

• Primary Outcome: Two year disease free survival
• Secondary Outcome: Overall survival, Progression free survival, R0 resection rate, Response rate of diagnostic imaging, Pathological chemotherapy effect, Adverse events, Rate of preoperative treatment completion, Rate of protocol achievement, Surgical complication

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1.Resectable pancreatic cancer (JPS7th)
2.Pathological or cytologically proven invasive ductal adenocarcinoma or adenosquamous carcinoma
3.No distant metastasis
4.Age over 20 or under 80
5.ECOG performance status 0-1
6.No history of chemo therapy within 3 years.
7.No history of pancreatic cancer therapy
8.No problems for oral intake
9.Neither peripheral sensory neuropathy nor peripheral motor neuropathy
10.In the case of obstructive jaundice, appropriate bileduct drainage is performed
11.No findings of gastrointestinal infiltration protruding into the lumen and or gastrointestinal bleeding
12.The latest inspection value within 2 weeks before registration satisfies all of the following.
1) White blood cell count more than 3,000 / mm 3
2) Hemoglobin more than 9.0 g / dL (no transfuse within 7 days before registration)
3) Platelet count more than 10 x 10 4 / mm 3
4) Albumin more than 3.0 g / dL
5) Total bilirubin less than 2.0 mg / dL (3.0 mg / dL or less in case of bileduct drainarge)
6) AST less than 100 U / L (150 IU / L or less in case of bileduct drainarge)
7) ALT less than 100 U / L (150 IU / L or less in case of bileduct drainarge)
8) Serum creatinine less than 1.2 mg / dL
9) Creatinine clearance 50 ml / min or more
13.Written informed consent

Exclude criteria

1.GEM, nab-PTX or fluorinated pyrimidine anticancer drugs have been treated.
2.Severe diarrhea with uncontrolled bowel movement
3.Phenytoin, warfarin potassium, flucytosine are used.
4.History of sever allergic reaction with nab-paclitaxel, paclitaxel or albumin
5.Drug allergy to iodine contrast medium and impossible to perform contrast CT imaging. However, do not exclude the case of contrast-enhanced CT imaging with steroid prophylaxis.
6.Pulmonary fibrosis or interstitial pneumonia
7.Patients with medium or more pleural effusion or ascites
8.Active infection (Clinically stable HBV and chronic viral hepatitis by HCV are excluded).
9.Uncontrolled diabetes
10.Active double cancer (Synchronous double cancer and metachronous double cancer with disease-free period within 3 years). However, lesions such as carcinoma in situ that are cured by topical therapy are not included in active double cancers.
11.Active digestive ulcer
12.Serious complications (heart failure, renal failure, liver failure, intestinal palsy, etc).
13.Myocardial infarction within six months
14.Continuous systemic administration of steroids
15.Sever mental disorder
16.Women who are pregnant / lactating or pregnant or willing, or wish to baby.
17.A man who wishes to become a partner's pregnant.
18.Inappropriate physical condition as diagnosed by the attending physician

Related Information

• Primary Sponsor: Hirano Satoshi
• Secondary ID(s): UMIN000031822