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

ConditionsPancreas CancerLocally AdvancedLocally Advanced Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Distant metastasis from pancreas cancer.

Contraindication to having a magnetic resonance imaging (MRI) scan.

Prior abdominal radiation therapy.

Malignancy treated with curative intent and with no known active disease for at least 3 years before enrollment on this study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Ablative Body Radiation (SABR)

    Radiation

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

  • Tumor Treating Fields (TTF)

    Device

    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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

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

Time frame
1 and 2 years
2

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).

Time frame
2 years
3

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).

Time frame
1 and 2 years
4

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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baptist Health South Florida

Lead sponsor

NovoCure Ltd.

Collaborator

Source ClinicalTrials.gov
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