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RecruitingInterventional

Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer

NCT ID: NCT05679674Sponsor: Baptist Health South FloridaLast updated: 2026-01-12

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.

Arms & interventions

  • RadiationStereotactic Ablative Body Radiation (SABR)

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

  • DeviceTumor 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 additional treatment break is permitted for up to 48 hours every 21 days.

Outcome measures

Primary

  • 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

    Time frame: 2 years

Secondary

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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. Exclusion Criteria: * 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: 1. Malignancy treated with curative intent and with no known active disease for at least 3 years before enrollment on this study. 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3. 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 \[gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes\].

Study locations (1)

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176

Recruiting
Michael Chuong, M.D. · Contact

References

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  • 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.(PubMed)
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  • 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.(PubMed)