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New treatment option for Pancreatic Cancer
Official title Intraoperative Radiation Therapy After Stereotactic Body Radiation Therapy and Chemotherapy in Treatment of Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT05141513
What this study is testing
- What it's testing
- This study is designed to investigate the safety of intraoperative radiation therapy (IORT) in patients with localized pancreatic cancer undergoing surgical resection after neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years old
- Resectable/BRPC/LAPC as defined by NCCN guidelines (Figure 1) as follows confirmed via CT, EUS, or other imaging modalities.
- ECOG performance status 0-2
- Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the...
- Candidate for SBRT at JHU
You likely can't join if
- Previous thoracic/abdominal radiation therapy
- Unable to receive SBRT at JHU
- Duodenal invasion detected on imaging which would exclude candidacy for SBRT
- Tumor located in pancreatic body or tail
- Unable to undergo Whipple procedure
- Evidence of disease not localized to the pancreas
See the full eligibility criteria
- Age \> 18 years old
- Resectable/BRPC/LAPC as defined by NCCN guidelines (Figure 1) as follows confirmed via CT, EUS, or other imaging modalities.
- ECOG performance status 0-2
- Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
- Candidate for SBRT at JHU
- Upfront treatment with multi-agent chemotherapy
- Candidate for surgical exploration at JHU
- Previous thoracic/abdominal radiation therapy
- Unable to receive SBRT at JHU
- Duodenal invasion detected on imaging which would exclude candidacy for SBRT
- Tumor located in pancreatic body or tail
- Unable to undergo Whipple procedure
- Evidence of disease not localized to the pancreas
- Any arterial reconstruction during surgery
- Currently enrolled in another investigational drug or device trial that clinically interferes with this study
- Unable to comply with study requirements or follow-up schedule
- Women of child bearing potential or sexually active fertile men with partners who are women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.