Stereotactic Body Radiation And Tumor Treating Fields For Locally Advanced Pancreas Cancer

Study Overview

Stereotactic Body Radiation 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.

N/A

Pancreas Cancer
Locally Advanced
Locally Advanced Pancreatic Adenocarcinoma

RADIATION: Stereotactic Ablative Body Radiation (SABR)
DEVICE: Tumor Treating Fields (TTF)

2020-CHU-003

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-12-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-05
First Submitted that Met QC Criteria 2022-12-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-10
First Posted (ACTUAL) 2023-01-11	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Stereotactic Ablative Body Radiation (SABR) and 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	RADIATION: Stereotactic Ablative Body Radiation (SABR) 50 Gy in 5 fractions, once per day for 5 days DEVICE: Tumor Treating Fields (TTF) 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 additi

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Stereotactic Ablative Body Radiation (SABR) and 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

RADIATION: Stereotactic Ablative Body Radiation (SABR)

50 Gy in 5 fractions, once per day for 5 days

DEVICE: Tumor Treating Fields (TTF)

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 additi

Primary Outcome Measures	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures	Measure Description	Time Frame
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	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).	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).	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	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	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.	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.	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.	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.	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.	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.	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Michael Chuong, M.D.

Phone Number: (786) 596-2000

Email: MichaelChu@baptisthealth.net

Study Contact Backup

Name: Carolina Rojas

Phone Number: (786) 527-8543

Email: CarolinaRoj@BaptistHealth.net

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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.

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.
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].

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

NovoCure Ltd.

Investigators

PRINCIPAL_INVESTIGATOR: Michael Chuong, M.D., Miami Cancer Institute at Baptist Health, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.
Rudra 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.
Chuong 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.
Jo 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.
Giladi 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.
Rivera 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.

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