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

Asan Medical Center0 个研究点目标入组 92 人开始时间: 待定最近更新: 2023年5月2日

适应症

试验速览

暂无简介。

•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.

•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

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