A Phase II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Pancreatic Carcinoma
The primary endpoint is feasibility and compliance of induction chemotherapy with
gemcitabine and cisplatin followed by CRT for locally advanced unresectable pancreatic
cancer. Previous studies showed that approximately 20% of patients with locally advanced
disease developed the early distant metastasis.[6, 7] Thus, it will be expected that at
least 80% of total patients will be eligible for induction chemotherapy after completion of
induction chemotherapy. An experimental arm that result a compliance of 80% would merit
further study. If the true compliance rate of the patients who will eligible for CRT is ≤
60%, null hypothesis will be rejected with a power of 80% and a type I error of 5%. Thus,
the required number of evaluable patients is 24. Considering the 10% follow-up loss and 20%
distant metastasis rate after induction chemotherapy, a total of 34 eligible patients will
be enrolled.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
feasibility and compliance
to evaluate acute and late toxicity of induction chemotherapy with gemcitabine and cisplatin followed by chemoradiotherapy for unresectable pancreatic cancer.
Up to 1 year
Yes
Woo Jin Lee, Ph.D
Principal Investigator
National Cancer Center, Korea
Korea: Food and Drug Administration
NCCCTS-11-567
NCT01593475
March 2012
August 2014
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