Pancreatic Adenocarcinoma, Pancreatic Cancer Non-resectable
Conditions
Keywords
Pancreatic adenocarcinoma, Locally advanced unresectable, mFOLFIRINOX, Stereotactic body radiotherapy
Brief summary
Modified FOLFIRINOX (mFOLFIRINOX) is the standard of care for patients with locally advanced pancreatic adenocarcinoma. While radiotherapy has been investigated for the management of resectable or locally advanced pancreatic adenocarcinoma, its role in the era of modern chemotherapy is not clear. Stereotactic body radiotherapy (SBRT) is the novel technique of radiotherapy to enhance the dose of radiotherapy to the target tumor lesion. This trial aims to compare the efficacy and safety of mFOLFIRINOX with or without SBRT in patients with locally advanced pancreatic adenocarcinoma
Interventions
RADIATIONSBRT+mFOLFIRINOX
Stereotactic body radiotherapy: 3500 cGy (5 fractions) mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2
DRUGmFOLFIRINOX
mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Age 19 years or greater * Cytologically or histologically confirmed pancreatic adenocarcinoma * Locally advanced unresectable disease per National Comprehensive Cancer Network resectability criteria * No active infection except chronic hepatitis on anti-viral therapy * Eastern Cooperative Oncology Group performance status 0 or 1 * Body weight \> 30 kg * Normal organ and bone marrow function
Exclusion criteria
* Gastrointestinal obstruction * Active gastrointestinal bleeding or ulcer * Clinically significant cardiac disease or myocardial infarction within 6 months before the randomization * Histology other than adenocarcinoma (adenosquamous or neuroendocrine tumors) * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year progression-free survival rate | 1 year | Proportion of patients without disease progression or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 year | Time between randomization and death of any cause |
| Progression-free survival | 1 year | Time between randomization and disease progression or death of any cause |
| Overall response rates | 1 year | Tumor response per Response Evaluation Criteria in Solid Tumors version 1.1 |
| Adverse events | 1 year | Any unintended events graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5 |
| Surgical resection rate | 1 year | Proportion of patients who underwent curative-intent surgery |
Countries
South Korea
Outcome results
None listed