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

Primary Purpose

Pancreas Cancer, Locally Advanced, Locally Advanced Pancreatic Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Ablative Body Radiation (SABR)
Tumor Treating Fields (TTF)
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring tumor treating fields, stereotactic ablative body radiation, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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].

Sites / Locations

  • Miami Cancer Institute at Baptist Health, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in 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
Median Local Control (LC)
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).
Change in Local Control (LC)
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).
Median Distant Metastasis Free Survival (DMFS)
DMFS is defined as the time from initiation of study therapy to the first radiographic confirmation of distant metastasis
Change in Distant Metastasis Free Survival (DMFS)
DMFS is defined as the time from initiation of study therapy to the first radiographic confirmation of distant metastasis
Median Overall Survival (OS)
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.
Change in Overall Survival (OS)
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.
Change in Quality of Life (QOL)
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.
Change in Incidence of Grade 3+ Toxicities
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.
Location of Recurrence
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.
Chemotherapy-Free Interval
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.

Full Information

First Posted
December 27, 2022
Last Updated
June 14, 2023
Sponsor
Baptist Health South Florida
Collaborators
NovoCure Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05679674
Brief Title
Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer
Official Title
Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida
Collaborators
NovoCure Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Locally Advanced, Locally Advanced Pancreatic Adenocarcinoma
Keywords
tumor treating fields, stereotactic ablative body radiation, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF)
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Ablative Body Radiation (SABR)
Intervention Description
50 Gy in 5 fractions, once per day for 5 days
Intervention Type
Device
Intervention Name(s)
Tumor Treating Fields (TTF)
Other Intervention Name(s)
NovoTTF-100L
Intervention Description
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.
Primary Outcome Measure Information:
Title
Median Progression Free Survival (PFS)
Description
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 Outcome Measure Information:
Title
Change in Progression Free Survival (PFS)
Description
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
1 and 2 years
Title
Median Local Control (LC)
Description
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).
Time Frame
2 years
Title
Change in Local Control (LC)
Description
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).
Time Frame
1 and 2 years
Title
Median Distant Metastasis Free Survival (DMFS)
Description
DMFS is defined as the time from initiation of study therapy to the first radiographic confirmation of distant metastasis
Time Frame
2 years
Title
Change in Distant Metastasis Free Survival (DMFS)
Description
DMFS is defined as the time from initiation of study therapy to the first radiographic confirmation of distant metastasis
Time Frame
1 and 2 years
Title
Median Overall Survival (OS)
Description
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.
Time Frame
2 years
Title
Change in Overall Survival (OS)
Description
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.
Time Frame
1 and 2 years
Title
Change in Quality of Life (QOL)
Description
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.
Time Frame
Baseline, during radiation therapy, every 3 months for 2 years
Title
Change in Incidence of Grade 3+ Toxicities
Description
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.
Time Frame
Baseline, during radiation therapy, every 3 months for 2 years
Title
Location of Recurrence
Description
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.
Time Frame
2 years
Title
Chemotherapy-Free Interval
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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].
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Chuong, M.D.
Phone
(786) 596-2000
Email
MichaelChu@baptisthealth.net
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Rojas
Phone
(786) 527-8543
Email
CarolinaRoj@BaptistHealth.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Chuong, M.D.
Organizational Affiliation
Miami Cancer Institute at Baptist Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Cancer Institute at Baptist Health, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Chuong, M.D.
Phone
786-596-2000
Email
MichaelChu@baptisthealth.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33665480
Citation
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.
Results Reference
background
PubMed Identifier
30932367
Citation
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.
Results Reference
background
PubMed Identifier
32947042
Citation
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.
Results Reference
background
PubMed Identifier
33074042
Citation
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.
Results Reference
background
PubMed Identifier
24555979
Citation
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.
Results Reference
background
PubMed Identifier
30396819
Citation
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.
Results Reference
background
Links:
URL
https://cancer.baptisthealth.net/
Description
Miami Cancer Institute at Baptist Health

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

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