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Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer

StatusRecruiting
PhaseNot applicable
Started2023-09-21
View on ClinicalTrials.gov ↗

Amendment history

2026-01-08
2 amendments v8-v9
2 re-verifications since 2025-09-18, no change to tracked fields
2024-12-05
Study Status, Sponsor/Collaborators, Eligibility v7
Lead sponsorMichael Chuong→Baptist Health South Florida
Eligibility criteria+33 characters
[...] ncology Group (ECOG) performance status of 0 or 1. At least 43 months of prior FOLFIRINOX or, modified FOLFIRINOX, and/or gemcitabine/nab-paclitaxel delivered for pancreas cancer without evidence of distant p [...] radiographic studies. Carbohydrate antigen 19-9 (CA 19-9) ≤250500 U/mL on most recent assessment prior to study enrollment. A [...]
2024-03-30
Study Status, Sponsor/Collaborators v6
Lead sponsorBaptist Health South Florida→Michael Chuong
2024-01-17
Study Status v5
Start date2023-05-17→2023-09-21
2023-06-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06→confirmed 2023-05-17
Study sitesdetails revised at 1 of 1 site
Show 3 earlier versions
2023-05-01
Study Status v3
Primary completion date2027-04→2027-06
Completion date2027-04→2027-06
Start date2023-04→2023-06
2023-03-29
Study Status v2
Primary completion date2027-03→2027-04
Completion date2027-03→2027-04
Start date2023-03→2023-04
2023-02-06
Study Status v1
Primary completion date2027-01→2027-03
Completion date2027-01→2027-03
Start date2023-01→2023-03
2022-12-27
Original filing
The purpose of this clinical trial is to determine whether using chemotherapy followed by stereotactic ablative body radiation therapy (SABR) and tumor treating fields (TTF) will slow tumor growth in people with locally advanced pancreas cancer. All participants will receive SABR therapy once per day for five days and use the TTF system for at least 18 hours per day starting on the first day of SABR until the tumor progresses or severe toxicity develops.
Trial Details
NCT Number NCT05679674
Lead Sponsor Baptist Health South Florida
Collaborators: NovoCure Ltd.
Conditions Pancreas Cancer, Locally Advanced, Locally Advanced Pancreatic Adenocarcinoma
Enrollment 48 participants
Start Date 2023-09-21
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-12