Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
NCT ID: NCT01458717
Last Updated: 2018-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
58 participants
INTERVENTIONAL
2011-11-30
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neoadjuvant
Neoadjuvant - operation - maintenance chemotherapy
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
Upfront surgery
Operation - adjuvant chemoradiation - maintenance chemotherapy
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin-Young Jang
Associate professor
Principal Investigators
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Jin-Young Jang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine
Locations
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Center for Liver Cancer, National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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BorderlinePancreas
Identifier Type: -
Identifier Source: org_study_id
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