GABARNANCE Trial

JRCT ID: jRCTs031180319

Registered date:18/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Borderline resectable pancreatic cancer
• Date of first enrollment: 21/06/2017
• Target sample size: 110
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

Primary Outcome

PhaseII part: R0 resection rate
PhaseIII part: Overall survival

Secondary Outcome

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)

Key inclusion & exclusion criteria

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

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Ikeda Masafumi
• Source(s) of Monetary Support: AMED
• Secondary ID(s): UMIN000026858