RECRUITING

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

Conditions

Pancreas Cancer Locally Advanced Locally Advanced Pancreatic Adenocarcinoma tumor treating fields stereotactic ablative body radiation chemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-21

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05679674

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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: 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 \[gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes\].

Inclusion Criteria

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

Contacts and Locations

Study Contact

Michael Chuong, M.D.

CONTACT

(786) 596-2000

MichaelChu@baptisthealth.net

Carolina Rojas

CONTACT

(786) 527-8543

CarolinaRoj@BaptistHealth.net

Principal Investigator

Michael Chuong, M.D.

PRINCIPAL_INVESTIGATOR

Miami Cancer Institute at Baptist Health, Inc.

Study Locations (Sites)

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176

United States

Collaborators and Investigators

Sponsor: Michael Chuong

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

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

Study Start Date2023-09-21

Study Completion Date2027-06

Study Record Updates

Study Start Date2023-09-21

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

tumor treating fields
stereotactic ablative body radiation
chemotherapy

Additional Relevant MeSH Terms

Pancreas Cancer
Locally Advanced
Locally Advanced Pancreatic Adenocarcinoma