Preoperative radiation therapy for patients with resectable pancreatic cancer

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

This study is testing whether giving radiation therapy before surgery can help people with resectable pancreatic cancer live longer and have better outcomes compared to standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Yonsei University (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Seoul)
• Trial ID: NCT05679583 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of preoperative stereotactic body radiation therapy (SBRT) combined with pancreatic resection and adjuvant chemotherapy in patients diagnosed with resectable pancreatic cancer. The study aims to improve overall survival, progression-free survival, and local and distant control rates compared to standard treatment approaches. By focusing on patients with borderline resectable or resectable pancreatic cancer, the trial seeks to provide insights into the efficacy of preoperative therapies in enhancing surgical outcomes. Participants will be closely monitored for their response to the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 years or older with histologically diagnosed adenocarcinoma of the pancreas that is deemed resectable.

Not a fit: Patients with unresectable pancreatic cancer or those with distant metastases will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with resectable pancreatic cancer.

How similar studies have performed: Previous studies have shown promising results with preoperative therapies in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Seoul

• Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Principal investigator: Ik Jae Lee — Severance Hospital
• Study coordinator: Ik Jae Lee

Conditions Pancreatic Cancer