mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-14

Study Completion Date

2025-12-14

Brief Summary

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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

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Detailed Description

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Conditions

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Pancreatic Adenocarcinoma Pancreatic Cancer Non-resectable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT+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

Group Type EXPERIMENTAL

SBRT+mFOLFIRINOX

Intervention Type RADIATION

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

mFOLFIRINOX

-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

Group Type ACTIVE_COMPARATOR

mFOLFIRINOX

Intervention Type DRUG

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

Interventions

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SBRT+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

Intervention Type RADIATION

mFOLFIRINOX

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No