Chemotherapy + SBRT for Pancreatic Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Active infection, Heart failure, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 5-6 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of standard chemotherapy with or without stereotactic body radiation therapy (SBRT) in patients with pancreatic cancer that has spread to a few locations. SBRT targets tumors precisely, potentially requiring fewer treatments and causing less harm to healthy tissue. The trial aims to improve tumor control, reduce the chance of further spread, and possibly increase survival. This trial may suit those with pancreatic cancer that has spread to limited areas, where SBRT can target the tumors. Participants should have a diagnosis of pancreatic cancer with up to five metastases, excluding the brain. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that stereotactic body radiation therapy (SBRT) for pancreatic cancer produces varying safety outcomes. Some studies report serious side effects in 0% to 34% of patients, indicating that while some experience significant side effects, others tolerate the treatment well.

This trial also includes standard chemotherapy, a common cancer treatment. Chemotherapy often causes side effects like nausea and fatigue, but these are well-understood and managed in medical settings.

In summary, while SBRT and chemotherapy can cause side effects, they are usually manageable. The goal of combining these treatments is to improve outcomes for patients with pancreatic cancer that has spread to a few areas. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining chemotherapy with stereotactic body radiotherapy (SBRT) for pancreatic cancer because this approach targets tumors more precisely. While standard care typically involves chemotherapy alone, SBRT delivers high doses of radiation directly to the cancerous tissues in just a few sessions. This precise targeting minimizes damage to surrounding healthy tissue and potentially enhances the effectiveness of the chemotherapy. By integrating these treatments, there is hope to improve outcomes and provide quicker relief for patients battling this tough-to-treat cancer.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that stereotactic body radiation therapy (SBRT) for pancreatic cancer can lead to an average survival time of 14 months and control the cancer in 85% of patients after one year. SBRT effectively targets and shrinks tumors while protecting healthy tissue, potentially resulting in fewer side effects. In this trial, some participants will receive SBRT alongside chemotherapy, which stops cancer cells from growing and spreading, while others will receive chemotherapy alone. Overall, combining SBRT with chemotherapy may better control tumors and extend the lives of patients with pancreatic cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Michael S. Rutenberg, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with a specific type of pancreatic cancer that has spread to a few other parts of the body. Participants must have had some success with standard chemotherapy, be in fairly good health, and not pregnant or breastfeeding. They should agree to use birth control and can provide tissue/blood samples.

Inclusion Criteria

I am willing to go back to the study site for follow-up visits.

Your hemoglobin level, a measure of how much oxygen-carrying protein is in your blood, should be at least 9.0 grams per deciliter.

Provide written informed consent

Exclusion Criteria

I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

I have had a heart attack in the last 6 months or have heart failure needing constant treatment.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive standard chemotherapy with or without stereotactic body radiation therapy. Group I undergoes SBRT once daily or every other day for 5 fractions, and both groups receive chemotherapy per standard of care.

5-6 weeks

Multiple visits for chemotherapy and radiation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 7 and 14 days, and then every 8-12 weeks for 2 years.

2 years

Follow-up visits at 7 and 14 days, then every 8-12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care Chemotherapy
• Stereotactic Body Radiation Therapy

Trial Overview

The study compares standard chemotherapy alone versus combining it with precise radiation therapy (SBRT) for treating limited-spread pancreatic cancer. SBRT targets tumors accurately, aiming to improve outcomes and survival while minimizing damage to healthy tissues.

How Is the Trial Designed?

Group I: Group I (SBRT, chemotherapy) Experimental Treatment 6 Interventions

Patients undergo SBRT QD or every other day for 5 fractions, and receive chemotherapy per standard of care.

Group II: Group II (chemotherapy) Active Control 5 Interventions

Patients receive chemotherapy per standard of care.

Standard of Care Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in United States as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in Canada as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in Japan as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in China as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Approved in Switzerland as Chemotherapy for:

• Various cancers including breast, lung, colon, pancreatic, and others

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Stereotactic body radiation therapy (SBRT) is an effective and safe treatment for locally advanced pancreatic cancer (LAPC), showing a local control rate of 81.9% at one year and a median overall survival of 11.6 months based on a study of 142 patients.

Integrating SBRT with chemotherapy (ChT) improved overall survival rates, particularly for patients under 70 years old and those who received chemotherapy before and after SBRT, with no patients experiencing severe toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can STEreotactic Body Radiation Therapy (SBRT) Improve the Prognosis of Unresectable Locally Advanced Pancreatic Cancer? Long-Term Clinical Outcomes, Toxicity and Prognostic Factors on 142 Patients (STEP Study). Comito, T., Massaro, M., Teriaca, MA., et al.[2023]

A 57-year-old patient with metastatic pancreatic cancer showed a partial response to first-line chemotherapy with nab-paclitaxel and gemcitabine, achieving a progression-free survival of 13 months and an overall survival of 20 months, indicating the treatment's efficacy.

While the treatment was effective, it did cause some side effects, including grade 3 leukopenia that required dose adjustments, but other non-hematological toxicities were manageable and mostly grade 2 or less.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term progression-free survival in a metastatic pancreatic cancer patient treated with first-line nab-paclitaxel and gemcitabine. Boeck, S., Haas, M., Kruger, S., et al.[2023]

In a systematic review of 32 clinical trials, the combination of gemcitabine, docetaxel, and capecitabine showed promising overall survival (OS) of 32.5 months in neoadjuvant settings, highlighting the potential of combination therapies in improving outcomes for pancreatic cancer patients.

The highest OS reported for second-line treatment was 35.5 months with gemcitabine plus cisplatin, indicating that effective second-line options exist, but there is a critical need for new strategies beyond chemotherapy to enhance treatment outcomes in pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy in Pancreatic Cancer: A Systematic Review. Hajatdoost, L., Sedaghat, K., Walker, EJ., et al.[2022]

In a study of 47 patients with locally advanced pancreas cancer, a strategy of initial chemotherapy followed by stereotactic body radiotherapy (SBRT) for those without metastatic progression resulted in a median overall survival of 20 months and a local control rate of 85%.

The approach minimized treatment for patients who developed early metastatic disease, and SBRT was delivered safely with only 9% of patients experiencing late Grade III toxicities, indicating a favorable safety profile while maintaining the effectiveness of systemic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction gemcitabine and stereotactic body radiotherapy for locally advanced nonmetastatic pancreas cancer. Mahadevan, A., Miksad, R., Goldstein, M., et al.[2022]

Patients with unresectable pancreatic carcinoma have very low survival rates, with less than 5% overall survival at 5 years, even with standard treatments like chemotherapy and radiation.

Stereotactic body radiation therapy (SBRT) offers a promising alternative, delivering treatment in just 3-5 days with minimal disruption to chemotherapy, showing excellent local control and acceptable toxicity, suggesting it could improve patient outcomes and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy (SBRT) for Unresectable Pancreatic Carcinoma. Stauder, MC., Miller, RC.[2021]

Stereotactic body radiation therapy (SBRT) shows promising local control rates of about 75% for locally advanced pancreatic cancer, but it does not significantly improve overall survival rates.

Patients undergoing SBRT may experience considerable gastrointestinal toxicities, with acute toxicities reaching up to 22% and late toxicities up to 44%, highlighting the need for standardized treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiotherapy for locally advanced pancreatic cancer: A systemic review]. Tonneau, M., Lacornerie, T., Mirabel, X., et al.[2021]

In a comprehensive analysis of 68 randomized controlled trials involving 14,908 patients, the chemotherapy regimens NSC-631570 and gemcitabine combined with NSC-631570 were found to significantly improve overall survival in patients with locally advanced and metastatic pancreatic adenocarcinoma.

For progression-free survival, the combination regimen PEFG (cisplatin + epirubicin + fluorouracil + gemcitabine) was the most effective, while PG (gemcitabine + pemetrexed) and FLEC (fluorouracil + leucovorin + epirubicin + carboplatin) were identified as the most hematologically toxic regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line chemotherapy regimens for locally advanced and metastatic pancreatic adenocarcinoma: a Bayesian analysis. Zhang, S., Xie, W., Zou, Y., et al.[2022]

Gemcitabine continues to be the primary drug used for treating both early and advanced pancreatic cancer, highlighting its central role in current treatment protocols.

Recent advancements in systemic therapy suggest that combination chemotherapy is becoming a promising new approach for patients with good performance status, potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in chemotherapy for pancreatic cancer. Sirohi, B., Singh, A., Dawood, S., et al.[2022]

In a study of 16 patients with locally advanced pancreatic cancer, the combination of a single 25 Gy stereotactic body radiotherapy (SBRT) session with gemcitabine chemotherapy resulted in a median survival of 11.4 months, comparable to conventional treatments.

While the treatment showed good local control, there was a notable incidence of late gastrointestinal toxicity, including duodenal ulcers, highlighting the need for careful monitoring of patients post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine chemotherapy and single-fraction stereotactic body radiotherapy for locally advanced pancreatic cancer. Schellenberg, D., Goodman, KA., Lee, F., et al.[2022]

The use of neoadjuvant stereotactic body radiation therapy (SBRT) for pancreatic cancer is on the rise, increasing from 0% in 2004 to 9.5% in 2015, particularly in patients with more advanced disease.

Patients receiving neoadjuvant chemo-SBRT showed improved overall survival rates and higher rates of R0 resection compared to those receiving chemotherapy or conventional radiation therapy, suggesting that SBRT may offer significant benefits in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant stereotactic body radiation therapy for nonmetastatic pancreatic adenocarcinoma. Jiang, W., Haque, W., Verma, V., et al.[2023]

In a study of 57 older patients (age ≥ 70) with localized pancreatic cancer, those who underwent surgical resection after chemotherapy and stereotactic body radiation therapy (SBRT) had significantly improved overall survival (29.1 months) compared to those who did not have surgery (7.0 months).

The treatment approach was found to be safe, with only 5.3% of patients experiencing late grade 3 radiation toxicity, suggesting that older patients should not be excluded from aggressive treatment options if they complete chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upfront Chemotherapy Followed by Stereotactic Body Radiation Therapy with or without Surgery in Older Patients with Localized Pancreatic Cancer: A Single Institution Experience and Review of the Literature. Reddy, AV., Sehgal, S., Hill, CS., et al.[2023]

Stereotactic body radiation therapy (SBRT) shows promising efficacy for patients with locally advanced pancreatic cancer, with a pooled 1-year overall survival rate of 51.6% and a median overall survival of 17 months based on a systematic review of 19 studies involving 1009 patients.

The treatment also demonstrated a 1-year locoregional control rate of 72.3%, with severe adverse events occurring in less than 10% of patients, suggesting that SBRT is a safe and effective option for inoperable pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. Petrelli, F., Comito, T., Ghidini, A., et al.[2023]

In a study of 119 patients with locally advanced pancreatic cancer, chemoradiation resulted in shorter overall survival (8.6 months) compared to gemcitabine alone (13 months), indicating that chemoradiation may be less effective.

The chemoradiation group experienced higher rates of severe toxic effects (grades 3-4) during both the induction and maintenance phases, suggesting that this treatment approach is more toxic than gemcitabine alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Locally advanced unresectable pancreatic cancer: Induction chemoradiotherapy followed by maintenance gemcitabine versus gemcitabine alone: Definitive results of the 2000-2001 FFCD/SFRO phase III trial]. Barhoumi, M., Mornex, F., Bonnetain, F., et al.[2022]

Citations

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sciencedirect.com

sciencedirect.com/science/article/pii/S0167814025052144

Long-Term outcomes of ablative stereotactic body radiation ...

The early study reported poor outcomes with mOS of 5.7 months and a 1-year OS of 5 %, and grade ≥ 2 GI toxicity was observed in 79 % of ...

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pmc.ncbi.nlm.nih.gov

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

Stereotactic body radiotherapy for pancreatic cancer

Results showed a median OS of 14 months, along with an excellent LC rate of 85 % at one year. The efficacy of combining immunotherapy with radiation in the ...

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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 ...

4.

advancesradonc.org

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

Ablative Five-Fraction Stereotactic Body Radiation Therapy ...

Pancreatic tumor resectability status was determined by multidisciplinary tumor board consensus after review of radiographic imaging and patient operability ...

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letswinpc.org

letswinpc.org/research/sbrt-more-effective/

Can SBRT Become More Effective?

The technology allows clinicians to shrink tumors more effectively and achieve more significant responses while sparing healthy surrounding ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT02716207

Phase ǀ Study on Pancreatic Cancer Treated by CyberKnife

Stereotactic body radiotherapy (SBRT) with CyberKnife for unresectable pancreatic tumor is a relatively new treatment option made available because of ...