Clinical trial NCT01458717: Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
Official title: Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pancreatic Cancer
Keywords: pancreas
cancer
borderline resectable
locally advanced
resectability
chemotherapy
radiation
chemoradiation
neoadjuvant
survival
prognosis
recurrence
response rate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 2-year survival rate
timeFrame: 2-year actual survival outcome
Secondary outcomes:
measure: Median survival
timeFrame: after at least of 2-years follow up of all participants
measure: 1-year survival rate
timeFrame: after at least of 1-year follow up of all participants
measure: R0 resection rate
timeFrame: within 3 weeks after operation
measure: curative resection rate
timeFrame: within 3 weeks after operation
measure: local recurrence
timeFrame: within at least 2-years follow up
measure: response rate after neoadjuvant chemoradiation
timeFrame: within 6 weeks after completion of neoadjuvant chemoradiation
measure: efficacy of imaging study after neoadjuvant chemoradiation
timeFrame: within 3 weeks after operation
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Center for Liver Cancer, National Cancer Center
state: Gyeonggi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Jin-Young Jang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: