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

Trial Summary

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.

What data supports the effectiveness of the treatment Chemotherapy + SBRT for Pancreatic Cancer?

Research shows that combination chemotherapy, which includes drugs like gemcitabine, has improved survival rates for pancreatic cancer patients compared to using a single drug. Additionally, chemoradiation (a combination of chemotherapy and radiation therapy) has been shown to be more effective than chemotherapy alone for locally advanced pancreatic cancer. ^{1 2 3 4 5}

Is the combination of chemotherapy and SBRT safe for treating pancreatic cancer?

Studies show that using chemotherapy with stereotactic body radiation therapy (SBRT) for pancreatic cancer generally has acceptable safety levels, but some patients may experience significant side effects, especially related to the digestive system. ^{6 7 8 9 10}

How does the treatment of Chemotherapy + SBRT for Pancreatic Cancer differ from other treatments?

This treatment combines standard chemotherapy with stereotactic body radiation therapy (SBRT), which is a precise form of radiation delivered in a shorter time frame (3-5 days) compared to conventional radiation therapy. This approach aims to improve local control and minimize disruption to chemotherapy schedules, potentially offering better outcomes for patients with unresectable pancreatic cancer. ^{7 8 11 12 13}

What is the purpose of this trial?

This phase II trial studies the effect of standard of care chemotherapy with or with out stereotactic body radiation therapy in treating patients with pancreatic cancer that has spread to a limited amount of places in the body (oligometastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with stereotactic body radiation therapy may help improve tumor control, decrease risk of tumor spreading more, decrease side effects, and prolong survival.

Research Team

Michael S. Rutenberg, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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) 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]

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]

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 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]

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 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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

First-line chemotherapy regimens for locally advanced and metastatic pancreatic adenocarcinoma: a Bayesian analysis. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Long-term progression-free survival in a metastatic pancreatic cancer patient treated with first-line nab-paclitaxel and gemcitabine. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Advances in chemotherapy for pancreatic cancer. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Chemotherapy in Pancreatic Cancer: A Systematic Review. [2022]

5. France 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]. [2022]

6. Switzerland 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. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy (SBRT) for Unresectable Pancreatic Carcinoma. [2021]

8. Switzerland 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). [2023]

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

Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. [2023]

10. France pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiotherapy for locally advanced pancreatic cancer: A systemic review]. [2021]

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

Induction gemcitabine and stereotactic body radiotherapy for locally advanced nonmetastatic pancreas cancer. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Neoadjuvant stereotactic body radiation therapy for nonmetastatic pancreatic adenocarcinoma. [2023]

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

Gemcitabine chemotherapy and single-fraction stereotactic body radiotherapy for locally advanced pancreatic cancer. [2022]