Biweekly chemotherapy with nab-Paclitaxel plus Gemcitabine for elderly patinents of unresectable pancreatic cancer

JRCT ID: jRCTs051190038

Registered date:16/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 16/08/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of biweekly Gemcitabine plus Nab-paclitaxel for elderly patients (over 75) with unresectable pancreatic cancer.

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Adverse event rate, incidence of severe adverse events, overall survival (proportion of 1-year survival and 2-year survival), progression free survival, dose intensity, disease control rate

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Pathologically-proven adenocarcinoma accompanied by diagnostic imaging consistent with pancreatic cancer
2) Diagnosed as UR-LA or UR-M by chest/abdominal/pelvic CT
3) Without uncontrollable pleural effusion or ascites
4) Age: 75 or more than 75 years old
5) ECOG Performance status (PS) of 0 or 1
6) Estimated life expectancy; more than three months
7) No prior chemotherapy or surgical treatment for pancreatic cancer (except for single laparotomy or digestive tract bypass surgery)
8) No prior treatment for other organ cancer within 6 months
9) Adequate function of major organs
10) Written informed consent

Exclude criteria

1) Patients who prefer standard schedule GnP therapy if applicable
2) Patients who prefer chemoradiation therapy if applicable
3) Severe comorbidities [such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes(HbA1c>=10%)]
4) History of unstable angina pectoris or myocardial infarction within 6 months before registration.
5) Synchronous or metachronous malignancies except for early cancer
6) Infectious diseases (such as HIV, active tuberculosis, or bacterial infection) requiring systemic treatment, except for viral hepatitis and old pulmonary tuberculosis
7) Severe psychological disorder
8) Continuous systemic medication of corticosteroid or immunosuppressant
9) Pulmonary fibrosis or interstitial pneumonia
10) The history of adverse reactions to both of iodinated contrast media and gadolinium contrast media
11) Patients who are judged to be ineligible by investigators

Related Information

• Primary Sponsor: Ikezawa Kenji
• Secondary Sponsor: Takada Ryoji