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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer

Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer: A Prospective Phase II Study

Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer (NCT05679583) is a Phase 2 interventional studying Pancreatic Cancer, sponsored by Yonsei University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Pancreatic cancer is a cancer with a poor prognosis and a high mortality rate. The prognosis of surgically resectable pancreatic cancer is better than that of unresectable pancreatic cancer. But the prognosis is still poor enough to report a 2-year disease-free survival rate of 47.0% despite the application of standard treatment. Preoperative chemotherapy or radiotherapy for pancreatic cancer has been performed for a long time, especially for locally advanced pancreatic cancer. However, there are very few studies on the application of preoperative chemotherapy or radiotherapy for borderline resectable or resectable pancreatic cancer. The PREOPANC trial is a representative randomized study to investigate the effect of preoperative chemo/radiation therapy in borderline resectable or resectable pancreatic cancer. As a result, the overall survival, progression-free survival, local control, and distant control rates were significantly superior in preoperative therapy group. However, when only patients with resectable pancreatic cancer were analyzed separately, there was no significant difference in overall survival rate or complete resection rate. In 2020, retrospective propensity score matching analysis using the national cancer database revealed that the addition of preoperative stereotactic body radiation therapy (SBRT) showed a significant increase in overall survival rate rather than preoperative chemotherapy alone. In addition, SBRT also showed a significant increase in overall survival rather than conventional fractionated RT. In summary, the current standard treatment for resectable pancreatic cancer is surgical resection, but a higher survival rate can be expected when preoperative therapy is added. However, there is no study that focused on the role of preoperative SBRT. Therefore, this study aims to confirm the effectiveness of adding preoperative SBRT alone in resectable pancreatic cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Pancreatic Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 25 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Histologically diagnosed adenocarcinoma of the pancreas 2. Resectable pancreatic cancer at the time of diagnosis - Resectable pancreatic cancer refers to cases in which all of the following conditions are met: 1. If the tumor does not reach the superior mesenteric vein or portal vein, or even if it does, it reaches within 180° 2. If the tumor does not reach the superior mesenteric artery, celiac artery, or common hepatic artery 3. In the absence of distant metastases 3) Patients aged 20 years or older at the time of diagnosis 4) General performance status is 0-2 based on the Eastern Cooperative Oncology Group (ECOG) standard 5) Patients who voluntarily decided to participate in this clinical study and signed the written willing to sign a consent form Who Should NOT Join This Trial: 1. If there is a history of radiation exposure to the abdomen 2. Pancreatic cancer that cannot be resected 3. When accompanied by distant metastasis 4. Patients who are currently judged to be difficult to undergo surgery based on general performance status, bone marrow, and kidney function tests 5. Patients with active or uncontrolled infection 6. Patients with uncontrolled heart disease 7. Pregnant or lactating women 8. Patients with a history of malignant tumor excluding skin epithelial carcinoma, except for malignant melanoma, stage 0 cervical cancer, and early thyroid cancer 9. Patients who have been treated for malignant tumors and have been cured for more than 5 years can participate in the study Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion criteria: 1. Histologically diagnosed adenocarcinoma of the pancreas 2. Resectable pancreatic cancer at the time of diagnosis * Resectable pancreatic cancer refers to cases in which all of the following conditions are met: 1. If the tumor does not reach the superior mesenteric vein or portal vein, or even if it does, it reaches within 180° 2. If the tumor does not reach the superior mesenteric artery, celiac artery, or common hepatic artery 3. In the absence of distant metastases 3) Patients aged 20 years or older at the time of diagnosis 4) General performance status is 0-2 based on the Eastern Cooperative Oncology Group (ECOG) standard 5) Patients who voluntarily decided to participate in this clinical study and signed the written informed consent Exclusion criteria: 1. If there is a history of radiation exposure to the abdomen 2. Pancreatic cancer that cannot be resected 3. When accompanied by distant metastasis 4. Patients who are currently judged to be difficult to undergo surgery based on general performance status, bone marrow, and kidney function tests 5. Patients with active or uncontrolled infection 6. Patients with uncontrolled heart disease 7. Pregnant or lactating women 8. Patients with a history of malignant tumor excluding skin epithelial carcinoma, except for malignant melanoma, stage 0 cervical cancer, and early thyroid cancer 9. Patients who have been treated for malignant tumors and have been cured for more than 5 years can participate in the study

Treatments Being Tested

RADIATION

Preoperative Stereotactic body radiation therapy (SBRT), Pancreatic resection, Adjuvant Chemotherapy

1. Preoperative Stereotactic body radiation therapy (SBRT) For the gross pancreatic cancer lesion, 30 Gy/5 fx will be prescribed considering respiratory movement. And 20 Gy/5 fx will be prescribed to the triangle operation area including the common hepatic artery, celiac artery, and portal vein. 2. Pancreatic resection Surgical resection will be performed 2-4 weeks after the end of radiation therapy. The surgical method and resection range depend on the surgeon's judgment at the time of surgery. 3. Adjuvant Chemotherapy Adjuvant chemotherapy will be given under the judgment of the oncologist from 4 weeks after surgical resection, considering the pathological findings (R0 or R1 resection status, etc.) and the patient's medical condition. Adjuvant chemotherapy includes gemcitabine alone, gemcitabine plus capecitabine combination therapy, and mFOLFIRINOX.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Yonsei University Health System, Severance Hospital
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05679583), the sponsor (Yonsei University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05679583 clinical trial studying?

Pancreatic cancer is a cancer with a poor prognosis and a high mortality rate. The prognosis of surgically resectable pancreatic cancer is better than that of unresectable pancreatic cancer. But the prognosis is still poor enough to report a 2-year disease-free survival rate of 47.0% despite the application of standard treatment. Preoperative chemotherapy or radiotherapy for pancreatic cancer has been performed for a long time, especially for locally advanced pancreatic cancer. However, there are very few studies on the application of preoperative chemotherapy or radiotherapy for borderline re… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05679583?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05679583?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05679583. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05679583. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.