SBRT vs Conventional Radiation + Chemotherapy for Pancreatic Cancer

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must be taking: Chemotherapy

Must not be taking: Immune modulating agents

Disqualifiers: Metastatic disease, Prior malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5-6 weeks

102 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that patients taking nonprotocol-specified chemotherapy agents or immune modulating agents for other conditions cannot participate. It's best to discuss your current medications with the trial's principal investigator.

What data supports the effectiveness of the treatment Preoperative Fractionated Radiation Therapy and Chemotherapy, Stereotactic Body Radiation Therapy, Stereotactic Ablative Radiotherapy (SABR), CyberKnife for pancreatic cancer?

Research shows that stereotactic ablative radiation therapy (SABR) and stereotactic body radiation therapy (SBRT) using CyberKnife can be effective for treating locally advanced and metastatic pancreatic cancer, especially after initial chemotherapy. These treatments are known for their precision and shorter treatment times, which can be beneficial for patients. ^{1 2 3 4 5}

Is SBRT using CyberKnife safe for pancreatic cancer patients?

Studies have evaluated the safety of Stereotactic Body Radiation Therapy (SBRT) using CyberKnife for pancreatic cancer, showing it is generally safe for patients, including those with advanced or recurrent conditions. Safety has also been assessed in other cancers, like liver cancer, indicating it is a well-tolerated treatment option. ^{2 4 5 6 7}

How is the SBRT treatment different from other treatments for pancreatic cancer?

SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers high doses of radiation in a shorter time compared to conventional radiation, which can minimize disruption to chemotherapy schedules and potentially improve surgical outcomes and survival rates for pancreatic cancer patients. ^{8 9 10 11 12}

What is the purpose of this trial?

Patients are randomized into two arms. Arm A patients will receive Stereotactic Body Radiation Therapy (SBRT) and Arm B patients with receive conventional concurrent chemotherapy and radiation therapy.

Research Team

William Hall, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

Adults over 18 with a specific type of pancreatic cancer (type A adenocarcinoma) that is resectable, borderline resectable, or locally advanced. They should have had two months of chemotherapy without disease spread and be able to swallow pills. Pregnant women and those not using contraception are excluded.

Inclusion Criteria

Heme Onc (Chem 24) and cancer antigen (CA) 19-9/carcinoembryonic antigen (CEA) within 30 days prior to treatment, as follows:

Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3

Patient must provide study-specific informed consent prior to study entry.

Exclusion Criteria

Participation in another interventional clinical treatment trial while on study (observational trials are permitted).

I don't have any major health issues that would prevent me from having major pancreatic surgery.

Women who are lactating at the time of registration and who plan to be lactating through three months after study therapy is completed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive a minimum of one cycle of induction chemotherapy before randomization

4-6 weeks

Treatment

Participants are randomized to receive either Stereotactic Body Radiation Therapy (SBRT) or conventional concurrent chemotherapy and radiation therapy

5-6 weeks

Surgical Resection

Subjects undergo surgical resection within three to eight weeks following treatment

3-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Preoperative Fractionated Radiation Therapy and Chemotherapy
• Stereotactic Body Radiation Therapy

Trial Overview The trial compares two treatments for pancreatic cancer: Arm A receives Stereotactic Body Radiation Therapy (SBRT), while Arm B gets conventional chemotherapy alongside radiation therapy. Patients are randomly assigned to one of these groups.

Participant Groups

Group I: Stereotactic Body Radiation Therapy Experimental Treatment 1 Intervention

Patients undergo Stereotactic Body Radiation Therapy (25 to 35 Gy over five fractions)

Group II: Preoperative Fractionated Radiation Therapy and Chemotherapy Experimental Treatment 1 Intervention

Concurrent chemotherapy with radiation treatment (50.4 Gy over 28 fractions).

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Findings from Research

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 using the CyberKnife system showed a median survival of 9 months for patients with locally advanced and metastatic pancreatic cancer, with 37% of patients surviving for at least one year.

The treatment provided significant relief from abdominal pain within two weeks for 13 out of 20 patients, and it had a low toxicity profile, with only 20% experiencing mild nausea and no severe side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy using CyberKnife for locally advanced unresectable and metastatic pancreatic cancer. Su, TS., Liang, P., Lu, HZ., et al.[2018]

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]

Stereotactic body radiation therapy (SBRT) using CyberKnife demonstrated high local control rates for recurrent pancreatic adenocarcinoma, with 95.2% at 6 months and 62.1% at 24 months, indicating its efficacy in managing this challenging condition.

The treatment was generally safe, with 78.6% of patients experiencing symptom relief within about a week, although some patients did report mild to moderate acute toxicities, suggesting that while effective, careful monitoring is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for patients with recurrent pancreatic adenocarcinoma at the abdominal lymph nodes or postoperative stump including pancreatic stump and other stump. Zeng, XL., Wang, HH., Meng, MB., et al.[2020]

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]

This Phase I study aims to determine the maximum tolerated dose of CyberKnife stereotactic body radiation therapy (SBRT) for patients with locally advanced unresectable pancreatic cancer, using a regimen of five fractions with doses ranging from 7 Gy to 9.5 Gy.

The primary focus is on assessing gastrointestinal toxicity (grade III/IV) to establish safety, with a minimum of three patients treated at each dose level to identify the dose that causes limiting toxicity in at least two out of three patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose escalation of Stereotactic Body Radiotherapy (SBRT) for locally advanced unresectable pancreatic cancer patients with CyberKnife: protocol of a phase I study. Qing, SW., Ju, XP., Cao, YS., et al.[2022]

Cyberknife stereotactic ablative radiotherapy (SABR) demonstrated a 71.6% objective response rate in 53 patients with unresectable hepatocellular carcinoma (HCC), indicating its efficacy as a salvage treatment when other therapies failed.

The median survival time for patients treated with SABR was 20 months, with 1- and 2-year overall survival rates of 70.1% and 45.4%, respectively, suggesting that while SABR is effective, there is a need to address issues like out-field recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. Lo, CH., Huang, WY., Lee, MS., 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 104 patients with pancreatic cancer, those receiving stereotactic body radiation therapy (SBRT) had a higher rate of surgical resection (38.6%) compared to those receiving 3D/IMRT (23.4%), suggesting SBRT may facilitate more surgical options.

Overall survival rates were similar between SBRT and 3D/IMRT groups, with median survival of 29.6 months for SBRT and 24.1 months for 3D/IMRT, indicating that while SBRT is effective, it does not significantly improve survival compared to conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Versus Conventional Radiation Therapy for Patients With Pancreatic Cancer in the Modern Era. Abi Jaoude, J., Thunshelle, CP., Kouzy, R., et al.[2022]

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 body radiation therapy (SBRT) combined with chemotherapy for unresectable pancreatic cancer showed a median overall survival of 14.3 months and a local control rate of 79%, indicating its effectiveness in managing this challenging condition.

The treatment was generally well tolerated, with minimal acute toxicity, although there were some severe late toxicities, suggesting that while SBRT is a promising option, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy (SBRT) Combined With Chemotherapy for Unresected Pancreatic Adenocarcinoma. Gurka, MK., Kim, C., He, AR., 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]

References

1. 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]

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

Stereotactic body radiotherapy using CyberKnife for locally advanced unresectable and metastatic pancreatic cancer. [2018]

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

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

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

Stereotactic body radiation therapy for patients with recurrent pancreatic adenocarcinoma at the abdominal lymph nodes or postoperative stump including pancreatic stump and other stump. [2020]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Dose escalation of Stereotactic Body Radiotherapy (SBRT) for locally advanced unresectable pancreatic cancer patients with CyberKnife: protocol of a phase I study. [2022]

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

Stereotactic ablative radiotherapy for unresectable hepatocellular carcinoma patients who failed or were unsuitable for transarterial chemoembolization. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Stereotactic Versus Conventional Radiation Therapy for Patients With Pancreatic Cancer in the Modern Era. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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

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

Stereotactic Body Radiation Therapy (SBRT) Combined With Chemotherapy for Unresected Pancreatic Adenocarcinoma. [2022]

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

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