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

March 30, 2024 updated by: Michael Chuong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute at Baptist Health, Inc.
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 4 months of prior FOLFIRINOX or modified FOLFIRINOX delivered for pancreas cancer without evidence of distant progression on restaging radiographic studies.
  • Carbohydrate antigen 19-9 (CA 19-9) ≤250 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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 additional treatment break is permitted for up to 48 hours every 21 days.
Other Names:
  • NovoTTF-100L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Progression Free Survival (PFS)
Time Frame: 1 and 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
1 and 2 years
Median Local Control (LC)
Time Frame: 2 years
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)
Time Frame: 1 and 2 years
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)
Time Frame: 2 years
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)
Time Frame: 1 and 2 years
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)
Time Frame: 2 years
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)
Time Frame: 1 and 2 years
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)
Time Frame: Baseline, during radiation therapy, every 3 months for 2 years
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
Time Frame: Baseline, during radiation therapy, every 3 months for 2 years
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
Time Frame: 2 years
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
Time Frame: 2 years
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

Collaborators and Investigators

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

Sponsor

Michael Chuong

Collaborators

NovoCure Ltd.

Investigators

  • Principal Investigator: Michael Chuong, M.D., Miami Cancer Institute at Baptist Health, Inc.

Publications and helpful links

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

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

September 21, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 30, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-CHU-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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