Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458717
• Other study ID #: BorderlinePancreas
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2011
• Est. completion date: January 2018

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

Description:

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer.

This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• >18 years old or <75 years old

• ECOG 0-2

• biopsy proven adenocarcinoma of the pancreas

• no history of previous chemotherapy

• borderline resectable pancreas cancer

• no distant metastasis

• WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3

• Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal

• Creatinine no greater than 1.5 times upper limit of normal

• informed consent

Exclusion Criteria:

• history of previous chemotherapy

• history of radiation at >25% area of bone marrow

• stage unspecified, with distant metastasis, recurrent pancreas cancer

• history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study

• pregnant, breast-feeding patient

• uncontrolled or active infection

• uncontrolled cardiopulmonary disease

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Neoadjuvant chemoradiation
Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/? 4 weeks rest, re-evaluation for resectability operation start maintenance chemotherapy within 4~6 weeks after operation with Gemcitabine 1000mg/? (D1, 8, 15) every 4 weeks, for 4 cycle

Procedure:
• Upfront surgery
Operation at time of diagnosis Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/? start maintenance chemotherapy within 4~6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/? (D1, 8, 15) every 4 weeks, for 4 cycle

Locations

Country	Name	City	State
Korea, Republic of	Center for Liver Cancer, National Cancer Center	Goyang	Gyeonggi
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year survival rate	2-year actual survival outcome	2-year actual survival outcome
Secondary	Median survival	calculated from overall survival with Kaplan-Meier method	after at least of 2-years follow up of all participants
Secondary	1-year survival rate	1-year actual survival rate	after at least of 1-year follow up of all participants
Secondary	R0 resection rate	according to pathology report after operation	within 3 weeks after operation
Secondary	curative resection rate	according to pathology report after operation	within 3 weeks after operation
Secondary	local recurrence	any point during the follow-up period	within at least 2-years follow up
Secondary	response rate after neoadjuvant chemoradiation	comparison of imaging study findings at pre- and post-neoadjuvant chemoradiation	within 6 weeks after completion of neoadjuvant chemoradiation
Secondary	efficacy of imaging study after neoadjuvant chemoradiation	comparison of pathology report and imaging study in patients who completed neoadjuvant chemoradiation	within 3 weeks after operation