NCT04986930Active, not recruitingPhase 2
mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma
Randomized Phase 2 Study of mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Patients With Locally Advanced Pancreatic Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 28 Jan 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 27 Jul 2021
- Start date
- 14 Aug 2021
- Primary completion date
- 23 Jan 2025
- Lead sponsor
- Asan Medical Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT04986930
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 92
- From 14 Aug 2021 to the primary completion date, 23 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant cardiac disease or myocardial infarction within 6 months before the randomization
Other illness
- Active gastrointestinal bleeding or ulcer
Other
- Gastrointestinal obstruction
- Histology other than adenocarcinoma (adenosquamous or neuroendocrine tumors)
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.