NCT01593475

Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma

A Phase II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Pancreatic Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial chose the induction chemotherapy with gemcitabine and cisplatin followed by Chemoradiotherapy (CRT) with gemcitabine to optimize the treatment for pancreas cancer patients with locally advanced disease and the purpose of this trial is to evaluate the efficacy of induction CT with gemcitabine and cisplatin followed by CRT for unresectable pancreatic carcinoma.

Detailed description

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.

Conditions

• Pancreatic Carcinoma Non-resectable

Interventions

Type	Name	Description
RADIATION	Induction chemotherapy followed by CCRT	Chemotherapy In one cycle (4-weeks), gemcitabine 1,000 mg/m2 will be given by 30-minute intravenous infusion on days 1, 8, and 15, and 1 hour infusion of CDDP was administered at a dose of 25 mg/m2 weekly diluted in 500 mL of normal saline to ensure adequate hydration 1 hour before the administration of gemcitabine. Gemcitabine 300mg/m2 will be given by 30-minute intravenous infusion weekly during CCRT will be started within 3 weeks after completion of 2 cycles of induction chemotherapy Radiotherapy \- Total dose of PGTV and PCTV were 55 Gy, 22 fractions and 44 Gy, 22 fractions, respectively.

Timeline

• Start date: 2011-09-05
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2012-05-08
• Last updated: 2018-01-03

Locations

1 site across 1 country: South Korea