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

Last updated: December 5, 2024
Sponsor: Baptist Health South Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Pancreatic Cancer

Treatment

Stereotactic Ablative Body Radiation (SABR)

Tumor Treating Fields (TTF)

Clinical Study ID

NCT05679674
2020-CHU-003
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced adenocarcinoma of thepancreas. Locally advanced pancreas cancer as per National Comprehensive CancerNetwork (NCCN) Guidelines.

  • Regional lymph node involvement is permitted if able to be treated with radiationtherapy.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • At least 3 months of prior FOLFIRINOX, modified FOLFIRINOX, and/orgemcitabine/nab-paclitaxel delivered for pancreas cancer without evidence of distantprogression on restaging radiographic studies.

  • Carbohydrate antigen 19-9 (CA 19-9) ≤500 U/mL on most recent assessment prior tostudy enrollment.

  • Adequate normal organ and marrow function as defined below: i. Hemoglobin ≥8.0 g/dL that may be achieved with transfusion ii. Absoluteneutrophil count (ANC) ≥1500 per mm^3 iii. Platelet count ≥60,000 per mm^3 iv. Serumbilirubin ≤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 (hormonalor barrier method of birth control, abstinence) prior to study entry and for theduration of study participation. Should a participant become pregnant or suspectthey are pregnant while participating in this study, they must inform the treatingphysician immediately.

  • Able to operate the tumor treating field (NovoTTF-100L) system independently or withassistance.

  • All participants must sign written informed consent.

Exclusion

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 atleast 3 years before enrollment on this study.

  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidenceof 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 irreversibletoxicity that is not reasonably expected to worsen by treatment on this study arepermitted 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 withevaluation of study treatment or interpretation of patient safety or study results.

  • Participants who are pregnant or breastfeeding. Patients with an electricalimplantable device in the torso. Examples of electrical implanted medical devicesinclude spinal cord stimulators, vagus nerve stimulators, pacemakers, anddefibrillators.

  • History of significant uncontrolled cardiovascular disease. Significant cardiacdisease includes second/third degree heart block; significant ischemic heartdisease; poorly controlled hypertension; congestive heart failure of the New YorkHeart Association (NYHA) Class II or worse.

  • History of arrhythmia that is symptomatic or requires treatment. Patients withatrial fibrillation or flutter controlled by medication are not excluded fromparticipation in the trial.

  • Known allergy to medical adhesives or conductive hydrogel [gel used onelectrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes].

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Stereotactic Ablative Body Radiation (SABR)
Phase:
Study Start date:
September 21, 2023
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida 33176
    United States

    Active - Recruiting

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