Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with BRPC.

JRCT ID: jRCTs051180104

Registered date:08/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 25/10/2016
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Neoadjuvant chemotherapy 2 courses of NAC-GA
1. Nab-paclitaxel (Day 1,8,15) 125mg/m2 30 min IV administration
2. Gemcitabine (Day 1,8,15) 1,000mg/m2 30 min IV administration

Outcome(s)

• Primary Outcome: Overall survival time from the first day of protocol therapy

Secondary Outcome

1. Recurrence-free survival from the first day of protocol therapy
2. Safety of the protocol therapy (adverse effects)
3. Morbidity
(>= grade III of the Clavien Dindo classification)
4. Response rate, disease control rate
5. Preoperative/postoperative tumor marker (CA 19-9, CEA), rate of normalization
6. Reduction rate of the maximum standardized uptake value on positron emission tomography-computed tomography (limited to institutions where positron emission tomography-computed tomography is available)
7. Chemotherapeutic effect (grade based on Evans' classification)
8. Resection rate
9. R0 resection rate
10. Surgical data (operative time, blood loss, transfusion, postoperative hospital day)
11. Overall morbidity rates (reoperation, rate of readmission, mortality)
12. Rate of patients undergoing postoperative adjuvant therapy (entry rate, completion rate)
13. Dose intensity
14. Quality of life regarding fatigue and malaise assessed by FACIT-F questionnaire (Japanese version)
15. Quality of life peripheral sensory neuropathy assessed by FACT/GOG-NTX subscale questionnaire (version 4; Japanese version)
16. Quality of life the Patient Neurotoxicity Questionnaire (PNQ)

Key inclusion & exclusion criteria

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

Include criteria

1. Primary tumor is confirmed to be pancreatic cancer from histology, cytology, or imaging study and cases matching borderline resectable-arterial (BR-A), borderline resectable- venous (BR-PV) according to NCCN guidelines(Version 2.2016)
2. Measurable lesions
3. No previous treatment
4. ECOG Performance status 0 or 1
5. Age 20-80 years
6. Main organs functions meet the following criteria (latest value within 14 days before registration). Leukocytes <= 12,000/mm3, Neutrophil >= 1,500/mm3, Hemoglobin >= 9.0 g/dL, Platelets >= 100,000/mm3, Total bilirubin < 2.0 mg/dL (<= 3.0 mg/dl in biliary drainage case), Serum creatinine <= 1.5 mg/dL, AST/ALT < 2.5 x ULN.
7. Signed and dated informed consent before enrolment.

Exclude criteria

1. Severe drug hypersensitivity or drug allergy
2. History of malignant tumors (*including that without recurrence in the past five years, intramucosal carcinoma requiring endoscopic curative resection, uterine cervical carcinoma requiring curative resection, basal cell carcinoma of the skin or Squamous cell carcinoma)
3. Active infectious disease
4. Peripheral sensory neuropathy (>= Grade 2)
5. Interstitial pneumonia or pulmonary fibrosis
6. Uncontrollable pleural effusion or ascites
7. Uncontrollable diabetes mellitus
8. Uncontrollable congestive heart failure, angina, hypertension, arrhythmia
9. Severe neurological/psychological symptoms
10. Diarrhea (Increase in fecal frequency and watery diarrhea)
11. Breast-feeding or pregnant / possibly pregnant, or women who do not agree to prevent conception, and both men and women without intention to use contraception during the period of the study and for a period of time (180 days) after the final administration of the investigational drug.
12. Additional cases the doctor deems inappropriate for the participation of the clinical trial
13. Meets the resectability status (resectable/unresectable) of NCCN guidelines (Version 2.2016) by the degree of progression according to MDCT.
14. Active hepatitis B

Related Information

• Primary Sponsor: Yamaue Hiroki
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO.,LTD.
• Secondary ID(s): UMIN000024154