The phase I,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer

JRCT ID: jRCTs061180045

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Locally-advanced pancreas cancer
• Date of first enrollment: 27/03/2015
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Patients were assigned to the following levels of GAS regimens. Nab-paclitaxel was administered intravenously at 125 mg/m2, followed by intravenous gemcitabine at 1000 mg/m2. A daily dose of S1 was defined based on the patient's body surface area as follows:<1.25m2, 60mg; 1.25-1.5m2, 80mg;>1.5m2, 100mg. S1 administered orally twice a day on days 1-7. The treatment cycle was repeated every 2 weeks. After 6 cycles of the GAS chemotherapy regimen, patients were reevaluated to assess resectability and response to the treatment.

Outcome(s)

Primary Outcome

Phase I: incidence of adverse event which apply for discontinuance criteria
Phase II: Two year survival rate, median survival time

• Secondary Outcome: All adverse events, Resection rate, R0 resection rate, response rate, histological efficacy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Histologically confirmed pancreatic cancer
2. Locally advanced pancreatic cancer on imaging examinations
3. Performance status (ECOG): 0 or 1
4. Initial therapy
5. Agreement with signature of applicant has obtained before initiation of therapy

Exclude criteria

(1)Severe allergy for medicine
(2)Patients with other malignant disease within 5 years
(3)Patients with active infection
(4)Patients with severe neuropathy (>Grade2)
(5)Patients with ileus
(6)Patients with interstitial pneumonia
(7)Patients with uncontrollable ascites or pleural fluid
(8)Patients with uncontrollable diabetes
(9)Patients with uncontrollable heart disease
(10)Patients with pregnant or possibly pregnant
(11)Patients who have judged not suitable for this study by doctor.

Related Information

• Primary Sponsor: Kondo Naru
• Secondary ID(s): UMIN000016630