SABR + TTF for Pancreatic Cancer

Overseen By Carla Salazar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michael Chuong

Must be taking: FOLFIRINOX, Gemcitabine/nab-paclitaxel

Disqualifiers: Distant metastasis, Prior abdominal radiation, Inflammatory bowel disease, Uncontrolled cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if combining chemotherapy with stereotactic ablative body radiation (SABR) and a device using electrical fields, known as tumor treating fields (TTF), can slow the growth of pancreatic cancer that has not spread. Participants will receive SABR once daily for five days and use the TTF device for at least 18 hours a day until their tumor progresses or they experience severe side effects. The trial seeks individuals diagnosed with locally advanced pancreatic cancer who have completed at least three months of specific chemotherapy treatments and whose cancer has not spread to distant sites.

As an unphased trial, this study offers patients the chance to explore innovative treatment combinations that may improve outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves specific treatments like SABR and TTF, it's best to discuss your current medications with the trial team to ensure there are no interactions.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that combining Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) is generally well-tolerated for treating pancreatic cancer. Studies have found that SABR can safely deliver high doses of radiation directly to the tumor while protecting the surrounding healthy tissue. In patients with inoperable pancreatic cancer, SABR with a dose of 50 Gy over five days has been administered without causing severe side effects.

Improvements in radiation therapy have made it safer, reducing the risk of serious side effects. For instance, reports indicate minimal late-stage digestive issues, which are important concerns in these treatments. This suggests that the treatment is relatively safe, although individual reactions can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) for pancreatic cancer because it introduces a novel approach to treatment. SABR delivers highly precise radiation in just five days, potentially reducing damage to surrounding healthy tissue compared to traditional radiation therapies. TTF, on the other hand, uses electric fields to disrupt cancer cell division and growth. This combination aims to enhance the effectiveness of treatment and slow disease progression more effectively than current standard treatments, which often rely on chemotherapy and traditional radiation over longer periods.

What evidence suggests that SABR and TTF could be effective for pancreatic cancer?

Research has shown that combining two treatments, SABR and TTF, may slow the growth of pancreatic cancer cells. In this trial, participants will receive both SABR, a type of radiation therapy effective in shrinking tumors that cannot be removed with surgery, and TTF, which uses electric fields to stop cancer cells from dividing. Many patients have experienced tumor reduction with SABR alone. When combined with TTF, the delay in tumor growth exceeds that of either treatment alone. Early results suggest this combination could more effectively manage advanced pancreatic cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Michael Chuong, MD

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic cancer who've had specific chemotherapy for at least 4 months without the cancer spreading. They must have good organ function, not be pregnant or breastfeeding, and can't have a history of certain diseases or electrical implants in their torso. Participants need to agree to use contraception and be able to operate or get help operating the TTF device.

Inclusion Criteria

I can use the NovoTTF-100L system by myself or with help.

I've had FOLFIRINOX treatment for pancreatic cancer without the cancer spreading.

People of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria

My pancreatic cancer has spread to distant parts of my body.

I don't have lasting side effects from cancer treatment above mild.

You cannot have an MRI scan for medical reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive chemotherapy prior to radiation therapy

Varies

Radiation

Participants receive stereotactic ablative body radiation therapy (SABR) once per day for five days

1 week

5 visits (in-person)

Tumor Treating Fields

Participants use the TTF system for at least 18 hours per day starting on the first day of SABR until tumor progression or severe toxicity develops

Until progression or severe toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests if chemotherapy followed by Stereotactic Ablative Body Radiation (SABR) therapy once daily for five days plus continuous Tumor Treating Fields (TTF) therapy can slow tumor growth in locally advanced pancreas cancer patients.

How Is the Trial Designed?

Group I: Stereotactic Ablative Body Radiation (SABR) and Tumor Treating Fields (TTF) Experimental Treatment 2 Interventions

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

Stereotactic Ablative Body Radiation (SABR) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy (SBRT) for:

• Pancreatic cancer
• Lung cancer
• Liver cancer
• Spine cancer

Approved in European Union as Stereotactic Ablative Radiotherapy (SABR) for:

• Pancreatic cancer
• Lung cancer
• Liver cancer
• Prostate cancer

Approved in Canada as Stereotactic Body Radiation Therapy (SBRT) for:

• Pancreatic cancer
• Lung cancer
• Liver cancer

Approved in Japan as Stereotactic Ablative Radiotherapy (SABR) for:

• Pancreatic cancer
• Lung cancer
• Liver cancer

Who Is Running the Clinical Trial?

Michael Chuong

Lead Sponsor

Trials

1

Recruited

50+

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

NovoCure Ltd.

Industry Sponsor

Trials

64

Recruited

6,100+

Ashley Cordova

NovoCure Ltd.

Chief Executive Officer

Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel

Uri Weinberg

NovoCure Ltd.

Chief Medical Officer since 2020

MD from an unspecified institution

Published Research Related to This Trial

Stereotactic ablative radiotherapy (SABR) shows promise as a treatment for inoperable pancreatic cancer, with only 8.1% of patients experiencing significant acute toxicities and a median overall survival of 8.4 months.

The study suggests that increasing the radiation dose (biological effective dose) could improve patient outcomes, but careful planning is necessary to minimize the risk of severe gastrointestinal toxicity, especially in patients with larger tumor volumes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) as primary, adjuvant, consolidation and re-treatment option in pancreatic cancer: scope for dose escalation and lessons for toxicity. Goldsmith, C., Plowman, PN., Green, MM., et al.[2018]

Stereotactic body radiation therapy (SBRT) for unresectable pancreatic cancer showed similar overall survival and disease control outcomes compared to conventional intensity modulated radiation therapy (IMRT), based on a retrospective review of 270 patients (44 SBRT and 226 IMRT).

SBRT was associated with significantly lower rates of acute gastrointestinal toxicity, fatigue, and hematologic toxicity compared to IMRT, indicating that SBRT may be a safer and more tolerable treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation vs. intensity-modulated radiation for unresectable pancreatic cancer. Park, JJ., Hajj, C., Reyngold, M., et al.[2022]

Stereotactic ablative radiation therapy (SABR) for metastatic pancreatic cancer showed significant effectiveness in reducing abdominal pain and decreasing the need for opioids, with a 46% relative reduction in opioid use after treatment.

In a study of 27 patients, SABR was found to be safe, with only 7% experiencing severe toxicity, and it resulted in a median overall survival of 7 months, indicating its potential as a palliative treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Utility of Stereotactic Ablative Radiation Therapy for Palliation of Metastatic Pancreatic Adenocarcinoma. Koong, AJ., Toesca, DAS., Baclay, JRM., et al.[2023]

The PANCOSAR trial is investigating the effectiveness of stereotactic ablative body radiotherapy (SABR) in improving overall survival and quality of life for patients with localized pancreatic ductal adenocarcinoma (PDAC) who are unfit for surgery or chemotherapy, involving a multicenter approach with a focus on patient-reported outcomes.

The study will compare the outcomes of patients receiving SABR combined with best supportive care against those receiving only best supportive care, assessing factors like pain relief, quality of life, and treatment-related toxicity over a 12-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy or best supportive care in patients with localized pancreatic cancer not receiving chemotherapy and surgery (PANCOSAR): a nationwide multicenter randomized controlled trial according to a TwiCs design. Doppenberg, D., Besselink, MG., van Eijck, CHJ., et al.[2023]

Stereotactic ablative body radiotherapy (SABR) demonstrated a high efficacy in treating inoperable liver tumors, with 72.7% of patients showing partial regression and 27.3% achieving complete remission three months post-treatment.

The treatment was well-tolerated, with no severe toxicity (grade 2 or higher) reported, and resulted in one- and two-year overall survival rates of 85.4% and 68.8%, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic ablative radiotherapy for the liver: a safe and effective treatment. Van De Voorde, L., Vanneste, B., Houben, R., et al.[2015]

In a study of 74 patients with locally advanced pancreatic cancer (LAPC) treated with chemotherapy followed by stereotactic ablative radiation therapy (SABR), the median overall survival was 19.6 months from diagnosis and 12.1 months from the start of SABR, indicating promising efficacy of this treatment approach.

SABR was found to be well-tolerated, with only a 2.7% rate of severe fatigue and late gastrointestinal toxicity, and better outcomes were associated with patients who had a Karnofsky Performance Status (KPS) score of ≥90, were younger than 70 years, and had no pain prior to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing patient selection for stereotactic ablative radiotherapy in patients with locally advanced pancreatic cancer after initial chemotherapy - a single center prospective cohort. Doppenberg, D., Lagerwaard, FJ., van Dieren, S., et al.[2023]

Stereotactic body radiotherapy (SBRT) is an effective treatment for pancreatic cancer, showing good tolerance and disease control, and may become a standard treatment option alongside chemoradiotherapy (CRT).

The combination of SBRT with chemotherapy could enhance treatment effects, although optimal doses and fractionation schedules for SBRT have yet to be established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy in pancreatic adenocarcinoma. de la Pinta, C.[2023]

In a phase 2 clinical trial involving 35 patients with borderline resectable (BR) and locally advanced (LA) pancreatic cancer, the combination of induction chemotherapy (gemcitabine and capecitabine) followed by stereotactic ablative radiation therapy (SABR) showed high rates of successful surgical resection, with 91.7% of surgeries resulting in R0 resection.

The treatment was well-tolerated, with no severe toxicities observed from SABR, and the study demonstrated promising overall survival rates, particularly for BR patients who underwent surgery, highlighting the potential efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a prospective phase 2 clinical trial of induction gemcitabine/capecitabine followed by stereotactic ablative radiation therapy in borderline resectable or locally advanced pancreatic adenocarcinoma. Quan, K., Sutera, P., Xu, K., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05679674

Stereotactic Body Radiation and Tumor Treating Fields for ... The purpose of this clinical trial is to determine whether using chemotherapy followed by stereotactic ablative body radiation therapy (SABR) and tumor ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10873666/

Stereotactic body radiotherapy for pancreatic cancer This systematic review aims to comprehensively summarize the current prospective evidence regarding Stereotactic Body Radiotherapy (SBRT) in various clinical ...

3. advancesradonc.org advancesradonc.org/article/S2452-1094(20)30159-7/pdf

Ablative Five-Fraction Stereotactic Body Radiation Therapy ... We performed an institutional review boardeapproved retrospective analysis and compiled data on patients with inoperable pancreatic tumors treated with SMART.

4. withpower.com withpower.com/trial/phase-pancreatic-neoplasms-2023-92e8f

SABR + TTF for Pancreatic Cancer Stereotactic ablative body radiotherapy (SABR) demonstrated a high efficacy in treating inoperable liver tumors, with 72.7% of patients showing partial ...

5. dmr.amegroups.org dmr.amegroups.org/article/view/9499/html

Emerging potential of tumor treating fields as a treatment ... demonstrated that the combination of TTFields and radiation therapy was more effective in delaying PDAC cell growth compared to monotherapy with either ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7897757/

Ablative Five-Fraction Stereotactic Body Radiation Therapy for ... Here, we report the first experience of patients with inoperable pancreatic cancer treated using the SMART technique to a prescription of 50 Gy in 5 fractions.

7. tandfonline.com tandfonline.com/doi/full/10.2147/CEG.S341189

Stereotactic Body Radiation Therapy for Locally Advanced ... Advances in SBRT delivery have allowed for the safe delivery of ablative doses, which provides an opportunity for advancing outcomes for this challenging to ...

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)09371-4/fulltext

Stereotactic MR-guided on-table adaptive radiation therapy ... Long-term outcomes include 2-year overall survival from diagnosis and SMART of 53.6 % and 40.5 %, respectively, and minimal late grade ≥ 3 GI ...

9. dmr.amegroups.org dmr.amegroups.org/article/view/9181/html

Ablative radiation therapy advances in pancreatic cancer - Chin Advancements within the field of radiation oncology has enabled safe delivery of dose escalated and ablative radiation therapy for pancreatic adenocarcinomas.