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

NCT05679674 | Recruiting DMC FDA Device

• 1 other identifier: 2020-CHU-003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pancreas Cancer; Locally Advanced; Locally Advanced Pancreatic Adenocarcinoma

Keywords

tumor treating fields; stereotactic ablative body radiation; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in Progression Free Survival (PFS)

  1 and 2 years

• Median Local Control (LC)

  2 years

• Change in Local Control (LC)

  1 and 2 years

• Median Distant Metastasis Free Survival (DMFS)

  2 years

• Change in Distant Metastasis Free Survival (DMFS)

  1 and 2 years

Study Arms (1)

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

Radiation: Stereotactic Ablative Body Radiation (SABR); Device: Tumor Treating Fields (TTF)

Interventions

Stereotactic Ablative Body Radiation (SABR) RADIATION

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

Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF)

Tumor Treating Fields (TTF) DEVICE

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.

Also known as: NovoTTF-100L

Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• i. 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.

You may not qualify if:

• 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.
• 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 \[gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes\].

Sponsors & Collaborators

• Baptist Health South Florida: lead
• NovoCure Ltd.: collaborator

Study Sites (1)

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 33665480 BACKGROUND

• 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.

  PMID: 30932367 BACKGROUND

• 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. Erratum In: Pract Radiat Oncol. 2021 May-Jun;11(3):e354. doi: 10.1016/j.prro.2021.01.002.

  PMID: 32947042 BACKGROUND

• 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.

  PMID: 33074042 BACKGROUND

• 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.

  PMID: 24555979 BACKGROUND

• 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.

  PMID: 30396819 BACKGROUND

Related Links

• Miami Cancer Institute at Baptist Health

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Michael Chuong, M.D.

  Miami Cancer Institute at Baptist Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Chuong, M.D.

CONTACT

(786) 596-2000; MichaelChu@baptisthealth.net

Carla Salazar

CONTACT

(786) 595-7073; Carla.SalazarMonteagudo@baptisthealth.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 11, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)