Phase 2 study of SBRT plus mFOLFIRINOX for locally advanced pancreatic cancer

Randomized phase 2 study of mFOLFIRINOX with or without stereotactic body radiotherapy in patients with locally advanced pancreatic adenocarcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005965

Enrollment

Registered

2021-03-05

Start date

2021-09-10

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Radiation : 1. Stereotactic body radiotherapy (SBRT) 3500 cGy (5 fractions) 2. mFOLFIRINOX, every 2 wks • Oxaliplatin, 85 mg/m2 IV at Day 1 • Leucovorin, 400 mg/m2 IV at Day 1 • Irinotecan, 15

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. > 19 years old 3. Histologically or cytologically diagnosed pancreatic cancer 4. Locally advanced pancreatic cancer defined by NCCN criteria 5. Eligible for SBRT (determined by radiation oncologist) 6. No active infection (except chronic viral hepatitis under antiviral therapy) 7. ECOG performance status 0 or 1 8. Body weight > 30 kg 9. Normal organ and bone marrow function 10. Willingness to follow clinical trial procedure 11. No other malignancy except the cases of non-melanoma skin cancer, cervical cancer insitu, localized prostate cancer or papillary thyroid cancer, or 5-recurrence free status of previous cancer.

Exclusion criteria

Exclusion criteria: 1. unwillingness to follow clinical trial procedure because of medical or psychological issues or previous history of non-compliance 2. gastrointestinal obstruction 3. active gastrointestinal bleeding or ulcer 4. myocardial infarction or other clinically significant cardiac disease within 6 months from study treatment 5. Severe systemic disase noe eligible for study participation determined by the study investigator 6. histology of adenocarcinoma-squmous cell carcinoma or neuroendocrine carcinoma mixed type 7. previous history of organ transplantation 8. pregnant or breast-feeding female or non-compliant male or female for effective birth protection between screening and 90 days from last dose of study treatment 9. known history of allergy or hypersensitivity on study drug

Design outcomes

Primary

Measure	Time frame
1-year progression-free survival rate	—

Secondary

Measure	Time frame
Overall survival;Response rate;Toxicity	—

Countries

Korea, Republic of

Contacts

Public ContactChanghoon Yoo

Asan Medical Center

cyoo.amc@gmail.com+82-2-3010-1727

Outcome results