Phase I study of nab-paclitaxel and gemcitabine CRT for BR and UR-LA PDAC

JRCT ID: jRCTs041180147

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Borderline resectable or locally advanced unresectable pancreatic cancer
• Date of first enrollment: 08/02/2018
• Target sample size: 18
• Study type: Interventional

Intervention(s)

Chemoradiotherapy
Chemotherapy: gemcitabine 600mg/m2 + Nab-paclitaxel X mg/m2 on day 1,15,29, and 43. X=75 (cohort 1), 100 (cohort 2), 125 (cohort 3)
Radiotherapy: 50.4Gy/28fr

Outcome(s)

• Primary Outcome: dose-limiting toxicity
• Secondary Outcome: Resection rate, overall survival, progression free survival,safety, histological effect

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both
• Include criteria: The cases who were diagnosed as Borderline resectable or locally advanced unresectable pancreatic cancer by MDCT and was histologically diagnosed as malignancy/adenocarcinoma by EUS-FNA or cytology of pancreatic juice

Exclude criteria

The patients who have the allergy of medication or severe infection
The patients who was considered to be inappropriate for this study

Related Information

• Primary Sponsor: Kishiwada Masashi
• Secondary ID(s): UMIN000030551