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A Safety Study of Intraoperative Radiation Therapy Following Stereotactic Body Radiation Therapy and Multi-agent Chemotherapy in the Treatment of Localized Pancreatic Adenocarcinoma

Who is this study for? Patients with localized pancreatic adenocarcinoma
What treatments are being studied? High Dose Rate Brachytherapy Intraoperative Radiation Therapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Amol Narang, MD
anarang2@jh.edu
410-502-3828
Backup
Dana B Kaplin, MPH
dkaplin1@jhmi.edu
410-502-3950
Time Frame
Start Date: 2022-05-06
Estimated Completion Date: 2028-04
Participants
Target number of participants: 25
Treatments
Other: Intra Operative Radiation Therapy (IORT) Group
The IORT group is the single arm of this study. Enrolled patients who undergo standard of care treatment will also receive a study treatment of High Dose Rate (HDR) Intra Operative Radiation Therapy.
Related Therapeutic Areas
Sponsors
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov