Pancreas CancerNCT05679674
Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer
A study testing Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) in people with Pancreas Cancer and Locally Advanced, run by Baptist Health South Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Locally Advanced, Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas. Locally advanced pancreas cancer as per National Comprehensive Cancer Network (NCCN) Guidelines.
- Regional lymph node involvement is permitted if able to be treated with radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least 3 months of prior FOLFIRINOX, modified FOLFIRINOX, and/or gemcitabine/nab-paclitaxel delivered for pancreas cancer without evidence of distant progression on restaging radiographic studies.
- Carbohydrate antigen 19-9 (CA 19-9) ≤500 U/mL on most recent assessment prior to study enrollment.
- Adequate normal organ and marrow function as defined below:
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- Hemoglobin ≥8.0 g/dL that may be achieved with transfusion ii. Absolute neutrophil count (ANC) ≥1500 per mm^3 iii. Platelet count ≥60,000 per mm^3 iv. Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN) v. AST (SGOT)/ALT (SGPT) ≤3 x institutional ULN
- People of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a participant become pregnant or suspect they are pregnant while participating in this study, they must inform the treating physician immediately.
- Able to operate the tumor treating field (NovoTTF-100L) system independently or with assistance.
- All participants must sign written informed consent.
Who cannot join
- Distant metastasis from pancreas cancer.
- Contraindication to having a magnetic resonance imaging (MRI) scan.
- Prior abdominal radiation therapy.
- History of any primary malignancy with the exception of:
- Malignancy treated with curative intent and with no known active disease for at least 3 years before enrollment on this study.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
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- Adequately treated carcinoma in situ without evidence of disease (i.e., cervical carcinoma in situ; superficial bladder cancer).
- Any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 > grade 2) from previous anti-cancer therapy. Participants with irreversible toxicity that is not reasonably expected to worsen by treatment on this study are permitted to enroll on this study.
- History of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis).
- Any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of patient safety or study results.
- Participants who are pregnant or breastfeeding. Patients with an electrical implantable device in the torso. Examples of electrical implanted medical devices include spinal cord stimulators, vagus nerve stimulators, pacemakers, and defibrillators.
- History of significant uncontrolled cardiovascular disease. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse.
- History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.
- Known allergy to medical adhesives or conductive hydrogel [gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes].
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Michael Chuong, M.D., 786-596-2000, MichaelChu@baptisthealth.net
About this study
Official title: Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer
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.
- Being tested
- Stereotactic Ablative Body Radiation (SABR), Tumor Treating Fields (TTF)
- Keywords
- tumor treating fields, stereotactic ablative body radiation, chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Ablative Body Radiation (SABR)Radiation
50 Gy in 5 fractions, once per day for 5 days
Tumor Treating Fields (TTF)Device
Also called NovoTTF-100L
Participant will use the system for at least 18 hours per day starting on the first day of SABR until abdominal disease progression. Short treatment breaks are permitted for personal needs (such as to take a shower) and during radiation therapy. An additional treatment break is permitted for up to 48 hours every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) | Experimental | 50 Gy in five fractions SABR (once per day for 5 days) and use of the TTF system for 18 hours per day starting on the first day of SABR and continuing until abdominal disease progression Receives: Radiation: Stereotactic Ablative Body Radiation (SABR); Device: Tumor Treating Fields (TTF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression Free Survival (PFS)
PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first
Measured: 2 years
Secondary outcomes (11)
Change in Progression Free Survival (PFS)
PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first
Measured: 1 and 2 years
Median Local Control (LC)
LC is defined as a response within the radiation target volume according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (i.e., percentage of participants with stable disease, partial response, or complete response).
Measured: 2 years
Change in Local Control (LC)
LC is defined as a response within the radiation target volume according to RECIST) v1.1 criteria (i.e., percentage of participants with stable disease, partial response, or complete response).
Measured: 1 and 2 years
Median Distant Metastasis Free Survival (DMFS)
DMFS is defined as the time from initiation of study therapy to the first radiographic confirmation of distant metastasis
Measured: 2 years
Change in Distant Metastasis Free Survival (DMFS)
DMFS is defined as the time from initiation of study therapy to the first radiographic confirmation of distant metastasis
Measured: 1 and 2 years
Median Overall Survival (OS)
OS is defined as the time from the initiation of study therapy to death due to any cause or date of last follow-up, whichever occurs first.
Measured: 2 years
Change in Overall Survival (OS)
OS is defined as the time from the initiation of study therapy to death due to any cause or date of last follow-up, whichever occurs first.
Measured: 1 and 2 years
Change in Quality of Life (QOL)
Quality of Life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire designed to measure four domains of QOL in cancer patients: physical, social, emotional, and functional well-being. Each domain has a scoring range of 0-28, for a combined total score of 0-108, where higher scores indicate better QOL.
Measured: Baseline, during radiation therapy, every 3 months for 2 years
Change in Incidence of Grade 3+ Toxicities
All participants will be evaluable for toxicity from the time of their first treatment. All Grade 3+ toxicities [according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0] will be tracked, regardless of attribution to study treatment.
Measured: Baseline, during radiation therapy, every 3 months for 2 years
Location of Recurrence
Location of recurrence is defined as the site(s) at the time of any first tumor recurrence: local only [centroid of the recurrence within the planning target volume (PTV)], distant only (centroid of the recurrence outside of the PTV), or local and distant.
Measured: 2 years
Chemotherapy-Free Interval
The chemotherapy-free interval is defined as the duration of time from the initiation of study therapy to the date any chemotherapy is subsequently administered.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start21 Sep 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- NovoCure Ltd.
- Responsible party
- Sponsor
- Investigators
- Michael Chuong, M.D., Principal investigator, Miami Cancer Institute at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679674
- Sponsor's protocol ID
- 2020-CHU-003
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hassanzadeh C, Rudra S, Bommireddy A, Hawkins WG, Wang-Gillam A, Fields RC, Cai B, Park J, Green O, Roach M, Henke L, Kim H. Ablative Five-Fraction Stereotactic Body Radiation Therapy for Inoperable Pancreatic Cancer Using Online MR-Guided Adaptation. Adv Radiat Oncol. 2020 Jun 25;6(1):100506. doi: 10.1016/j.adro.2020.06.010. eCollection 2021 Jan-Feb.
PubMed 33665480Rudra S, Jiang N, Rosenberg SA, Olsen JR, Roach MC, Wan L, Portelance L, Mellon EA, Bruynzeel A, Lagerwaard F, Bassetti MF, Parikh PJ, Lee PP. Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Med. 2019 May;8(5):2123-2132. doi: 10.1002/cam4.2100. Epub 2019 Apr 1.
PubMed 30932367Chuong MD, Bryant J, Mittauer KE, Hall M, Kotecha R, Alvarez D, Romaguera T, Rubens M, Adamson S, Godley A, Mishra V, Luciani G, Gutierrez AN. Ablative 5-Fraction Stereotactic Magnetic Resonance-Guided Radiation Therapy With On-Table Adaptive Replanning and Elective Nodal Irradiation for Inoperable Pancreas Cancer. Pract Radiat Oncol. 2021 Mar-Apr;11(2):134-147. doi: 10.1016/j.prro.2020.09.005. Epub 2020 Sep 16.
PubMed 32947042Jo Y, Oh G, Gi Y, Sung H, Joo EB, Lee S, Yoon M. Tumor treating fields (TTF) treatment enhances radiation-induced apoptosis in pancreatic cancer cells. Int J Radiat Biol. 2020 Dec;96(12):1528-1533. doi: 10.1080/09553002.2020.1838658. Epub 2020 Nov 2.
PubMed 33074042Giladi M, Schneiderman RS, Porat Y, Munster M, Itzhaki A, Mordechovich D, Cahal S, Kirson ED, Weinberg U, Palti Y. Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. Pancreatology. 2014 Jan-Feb;14(1):54-63. doi: 10.1016/j.pan.2013.11.009. Epub 2013 Dec 4.
PubMed 24555979Rivera F, Benavides M, Gallego J, Guillen-Ponce C, Lopez-Martin J, Kung M. Tumor treating fields in combination with gemcitabine or gemcitabine plus nab-paclitaxel in pancreatic cancer: Results of the PANOVA phase 2 study. Pancreatology. 2019 Jan;19(1):64-72. doi: 10.1016/j.pan.2018.10.004. Epub 2018 Oct 17.
PubMed 30396819
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer
- ClinicalTrials.gov ID
- NCT05679674
- Acronym / sponsor ID
- 2020-CHU-003
- Keywords
- tumor treating fields, stereotactic ablative body radiation, chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- NovoCure Ltd.
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) | Experimental | Radiation: Stereotactic Ablative Body Radiation (SABR), Device: Tumor Treating Fields (TTF)50 Gy in five fractions SABR (once per day for 5 days) and use of the TTF system for 18 hours per day starting on the first day of SABR and continuing until abdominal disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas. Locally advanced pancreas cancer as per National Comprehensive Cancer Network (NCCN) Guidelines.
- Regional lymph node involvement is permitted if able to be treated with radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least 3 months of prior FOLFIRINOX, modified FOLFIRINOX, and/or gemcitabine/nab-paclitaxel delivered for pancreas cancer without evidence of distant progression on restaging radiographic studies.
- Carbohydrate antigen 19-9 (CA 19-9) ≤500 U/mL on most recent assessment prior to study enrollment.
Key exclusion criteria (14 listed)
- Distant metastasis from pancreas cancer.
- Contraindication to having a magnetic resonance imaging (MRI) scan.
- Prior abdominal radiation therapy.
- History of any primary malignancy with the exception of:
- Any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 > grade 2) from previous anti-cancer therapy. Participants with irreversible toxicity that is not reasonably expected to worsen by treatment on this study are permitted to enroll on this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Ablative Body Radiation (SABR)50 Gy in 5 fractions, once per day for 5 days | Radiation | Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) |
| Tumor Treating Fields (TTF)Also: NovoTTF-100LParticipant will use the system for at least 18 hours per day starting on the first day of SABR until abdominal disease progression. Short treatment breaks are permitted for personal needs (such as to take a shower) and during radiation therapy. An additional treatment break is permitted for up to 48 hours every 21 days. | Device | Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) |
Primary outcome
Median Progression Free Survival (PFS)
Time frame: 2 years
PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first
11 secondary outcomes
Change in Progression Free Survival (PFS)
Time frame: 1 and 2 years
Median Local Control (LC)
Time frame: 2 years
Change in Local Control (LC)
Time frame: 1 and 2 years
Median Distant Metastasis Free Survival (DMFS)
Time frame: 2 years
Change in Distant Metastasis Free Survival (DMFS)
Time frame: 1 and 2 years
Median Overall Survival (OS)
Time frame: 2 years
Change in Overall Survival (OS)
Time frame: 1 and 2 years
Change in Quality of Life (QOL)
Time frame: Baseline, during radiation therapy, every 3 months for 2 years
Change in Incidence of Grade 3+ Toxicities
Time frame: Baseline, during radiation therapy, every 3 months for 2 years
Location of Recurrence
Time frame: 2 years
Chemotherapy-Free Interval
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 33665480Hassanzadeh C, Rudra S, Bommireddy A, Hawkins WG, Wang-Gillam A, Fields RC, Cai B, Park J, Green O, Roach M, Henke L, Kim H. Ablative Five-Fraction Stereotactic Body Radiation Therapy for Inoperable Pancreatic Cancer Using Online MR-Guided Adaptation. Adv Radiat Oncol. 2020 Jun 25;6(1):100506. doi: 10.1016/j.adro.2020.06.010. eCollection 2021 Jan-Feb.
- Background: PubMed 30932367Rudra S, Jiang N, Rosenberg SA, Olsen JR, Roach MC, Wan L, Portelance L, Mellon EA, Bruynzeel A, Lagerwaard F, Bassetti MF, Parikh PJ, Lee PP. Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Med. 2019 May;8(5):2123-2132. doi: 10.1002/cam4.2100. Epub 2019 Apr 1.
- Background: PubMed 32947042Chuong MD, Bryant J, Mittauer KE, Hall M, Kotecha R, Alvarez D, Romaguera T, Rubens M, Adamson S, Godley A, Mishra V, Luciani G, Gutierrez AN. Ablative 5-Fraction Stereotactic Magnetic Resonance-Guided Radiation Therapy With On-Table Adaptive Replanning and Elective Nodal Irradiation for Inoperable Pancreas Cancer. Pract Radiat Oncol. 2021 Mar-Apr;11(2):134-147. doi: 10.1016/j.prro.2020.09.005. Epub 2020 Sep 16.
- Background: PubMed 33074042Jo Y, Oh G, Gi Y, Sung H, Joo EB, Lee S, Yoon M. Tumor treating fields (TTF) treatment enhances radiation-induced apoptosis in pancreatic cancer cells. Int J Radiat Biol. 2020 Dec;96(12):1528-1533. doi: 10.1080/09553002.2020.1838658. Epub 2020 Nov 2.
- Background: PubMed 24555979Giladi M, Schneiderman RS, Porat Y, Munster M, Itzhaki A, Mordechovich D, Cahal S, Kirson ED, Weinberg U, Palti Y. Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. Pancreatology. 2014 Jan-Feb;14(1):54-63. doi: 10.1016/j.pan.2013.11.009. Epub 2013 Dec 4.
- Background: PubMed 30396819Rivera F, Benavides M, Gallego J, Guillen-Ponce C, Lopez-Martin J, Kung M. Tumor treating fields in combination with gemcitabine or gemcitabine plus nab-paclitaxel in pancreatic cancer: Results of the PANOVA phase 2 study. Pancreatology. 2019 Jan;19(1):64-72. doi: 10.1016/j.pan.2018.10.004. Epub 2018 Oct 17.
- Miami Cancer Institute at Baptist HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Chuong, M.D. principal investigator
Miami Cancer Institute at Baptist Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) in people with Pancreas Cancer and Locally Advanced, run by Baptist Health South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Chuong, M.D. ((786) 596-2000, MichaelChu@baptisthealth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Progression Free Survival (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05679674, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.