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Randomized phase II/III study of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer (GABARNANCE Trial )

GABARNANCE Trial (GABARNANCE Trial )

Ikeda Masafumi

National Cancer Center Hospital East

9-5-1, Kashiwanoha, Kashiwa, Chiba

masikeda@east.ncc.go.jp

Ikeda Masafumi

National Cancer Center Hospital East

9-5-1, Kashiwanoha, Kashiwa, Chiba

+81-4-7133-1111

masikeda@east.ncc.go.jp

Not Recruiting

Mar. 16, 2017

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Borderline resectable pancreatic cancer
2. Adenocarcinoma or adenosquamous carcinoma
3. No distant metastasis
4. Age 20-79
5. ECOG PS 0-1
6. No prior abdominal radiation therapy
7. No history of chemotherapy within last 3 years
8. No prior therapy for pancreatic cancer
9. Included in the irradiation field of 10cm x10cm
10. Able to eat orally
11. No sensory or motor neuropathy
12. Appropriate biliary drainage if bile duct obstructed
13. No radiological evidence of apparent intestinal cancer invasion and history of gastrointestinal bleeding
14. Meet all the criteria of laboratory examination
15. Informed consent by patient

1. History of gemcitabine, nab-paclitaxel and fluorouracil
2. poor control of diarrhea
3. Use of Coumadin, Phenytoin and Flucytosine
4. Allergic to gemcitabine and nab-paclitaxel
5. Computed tomography contrast media allergy
6. Intestinal pneumonia
7. Moderate amount of ascites or pleural effusion
8. Active infection
9. Poor control of diabetes mellitus
10. Ongoing active other malignancy
11. Active peptic ulcer
12. Serious comorbid conditions
13. Myocardial infarction within last 6 months
14. Systemic steroid therapy
15. Serious psychiatric diseases
16. Planning a baby or pregnancy
17. Planning a baby
18. Judged unable to guarantee safety

Both

Borderline resectable pancreatic cancer

Objective of the study is to evaluate safety and efficacy of gemcitabine and nab-paclitaxel therapy versus S-1 and concurrent radiotherapy as neoadjuvant treatment for Borderline resectable pancreatic cancer

Borderline resectable pancreatic cancer

C25

PhaseII part: R0 resection rate
PhaseIII part: Overall survival

PhaseII part: Incidence of adverse events
PhaseIII part: Progression free survival, R0 resection rate, 2 year survival rate, Radiological response rate, Histological response rate, Incidence of adverse events, Protocol compliance (completion rate of neoadjuvant therapy and overall therapy)

+81-4-7133-1111

Jan. 04, 2019

No

none