SABR + TTF for Pancreatic Cancer

Overseen By Carolina Rojas

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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of the treatment SABR + TTF for Pancreatic Cancer?

Research suggests that Stereotactic Ablative Body Radiation (SABR) can effectively target pancreatic tumors with high doses of radiation while minimizing damage to surrounding tissues, potentially improving disease control and quality of life for patients who cannot undergo surgery or chemotherapy. ^{1 2 3 4 5}

Is SABR/SBRT safe for treating pancreatic cancer?

Stereotactic Ablative Body Radiation (SABR) and Stereotactic Body Radiation Therapy (SBRT) are generally considered safe for treating pancreatic cancer, with studies suggesting they may have less toxicity compared to traditional radiation therapies. However, gastrointestinal side effects are a concern, and careful planning is needed to minimize these risks. ^{1 4 5 6 7}

How is the treatment SABR + TTF for pancreatic cancer different from other treatments?

Stereotactic Ablative Body Radiation (SABR) is unique because it delivers high doses of radiation directly to the tumor while minimizing damage to surrounding healthy tissue, potentially offering better tumor control and less toxicity compared to conventional radiation therapies. It is particularly useful for treating pancreatic cancer that cannot be surgically removed. ^{1 2 4 5 8}

Research Team

Michael Chuong, MD

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation vs. intensity-modulated radiation for unresectable pancreatic cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Utility of Stereotactic Ablative Radiation Therapy for Palliation of Metastatic Pancreatic Adenocarcinoma. [2023]

3. England 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. [2023]

4. Singapore pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy in pancreatic adenocarcinoma. [2023]

5. England 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. [2018]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic ablative radiotherapy for the liver: a safe and effective treatment. [2015]

8. Switzerland 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. [2023]