Cyberknife for Pancreatic Cancer

Overseen By Shirnett Williamson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Capital Health System, Inc

Disqualifiers: Pregnancy, Resectable cancer, Unresectable cancer, Pacemakers, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

10 Participants Needed

Trial Summary

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

The trial information does not specify whether 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 CyberKnife for pancreatic cancer?

Research shows that CyberKnife, a type of precise radiation therapy, has been promising for treating various cancers, including pancreatic cancer, by targeting tumors with high accuracy. Studies have indicated its potential in controlling cancer growth and improving quality of life, especially in cases where surgery is not an option. ^{1 2 3 4 5}

Is CyberKnife treatment generally safe for humans?

CyberKnife treatment, also known as stereotactic body radiation therapy (SBRT), has been studied for various cancers, including pancreatic, prostate, and liver cancers. Research indicates that it is generally safe, with promising local control and tolerance, although there are still some uncertainties about its long-term effects. ^{1 2 3 6 7}

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

Cyberknife is a unique treatment for pancreatic cancer because it uses advanced technology to deliver precise, high doses of radiation directly to the tumor, even in hard-to-reach areas, without the need for surgery. This approach can be particularly beneficial for patients with inoperable or recurrent tumors, offering a non-invasive option with the potential for good disease control and quality of life. ^{1 2 3 4 5}

What is the purpose of this trial?

The hypothesize that SBRT will limit or reverse tumor growth and thereby convert the borderline resectable disease or locally advanced disease in to a resectable tumor. Furthermore, we want to assess whether SBRT leads to an improved quality of life compared to IMRT.

Research Team

Shirnett Williamson, MD

Principal Investigator

Capital Health System, Inc

Eligibility Criteria

This trial is for adults over 18 with Stage I to III pancreatic cancer, who can understand the consent process and have an ECOG status of 0-1. They should not be pregnant, must have completed neoadjuvant chemotherapy, and their cancer shouldn't have spread or involve major arteries too much. It's not for those with a short life expectancy or certain medical devices.

Inclusion Criteria

I am approved for specific radiation therapy by a cancer treatment team.

My pancreatic cancer is confirmed to be Stage I to III with low arterial involvement.

My cancer has not spread to distant parts of my body.

Exclusion Criteria

I am not pregnant or breastfeeding and will use effective birth control during and for 6 months after treatment.

My pancreatic cancer cannot be removed with surgery.

Life expectancy of < 1 year

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive standard of care and neoadjuvant chemotherapy according to NCCN guidelines

Varies based on NCCN guidelines

Wash-out Period

A wash-out period of 4 weeks after chemotherapy before starting radiation therapy

4 weeks

Radiation Therapy

Participants receive either IMRT or SBRT radiation therapy

1.5-5.5 weeks

5 sessions (SBRT) or 28 sessions (IMRT)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for up to 12 months

12 months

4 visits (in-person)

Treatment Details

Interventions

• Cyberknife

Trial Overview The trial tests Cyberknife (SBRT) against IMRT in treating borderline resectable or locally advanced pancreatic adenocarcinoma. The goal is to see if SBRT can shrink tumors enough to make them operable and improve quality of life compared to IMRT.

Participant Groups

Group I: SBRT (Cyberknife) Experimental Treatment 1 Intervention

5-10 Gy/fraction. Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).

Group II: IMRT Active Control 1 Intervention

1.2-3 Gy/fraction up to 40 fractions. 15 mins daily (M-F) for a total of 28 sessions (5.5 weeks).

Cyberknife is already approved in United States, European Union for the following indications:

Approved in United States as CyberKnife System for:

• Tumors anywhere in the body, including pancreatic cancers and metastases

Approved in European Union as CyberKnife System for:

• Tumors anywhere in the body, including pancreatic cancers and metastases

Who Is Running the Clinical Trial?

Capital Health System, Inc

Lead Sponsor

Trials

1

Recruited

10+

Findings from Research

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]

CyberKnifeTM stereotactic body radiotherapy (SBRT) showed effectiveness in reducing the size of tumors in patients with advanced pancreaticobiliary malignancies, with an average decrease in tumor size observed in the first three months after treatment.

However, serious complications were reported, including two cases of massive duodenal ulcer bleeding, highlighting the need for careful monitoring and further studies to evaluate the safety and long-term efficacy of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An experience of cyberknife treatment in patients with advanced pancreaticobilliary malignancy]. Jung, YH., Choi, HS., Cheon, YK., et al.[2019]

Cyberknife stereotactic body radiation therapy (SBRT) delivers high doses of radiation in fewer sessions, making it a promising alternative to surgery for early-stage primary cancers and for patients with oligometastatic disease.

Despite some uncertainties about the effects of hypofractionation, early results show good local control and patient tolerance, leading to increased use of this treatment under strict quality assurance and ongoing clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. Thariat, J., Marcié, S., Marcy, PY., et al.[2018]

In a study of 29 prostate cancer patients treated with stereotactic body radiotherapy (SBRT) using a Cyberknife, PSA levels showed a significant decrease over time, with a median nadir of 0.329 ng/mL achieved after 23 months.

The treatment demonstrated a favorable safety profile, with only 3% of patients experiencing Grade 2 urinary toxicities and no severe late rectal toxicities reported, indicating that SBRT is a feasible option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. Lee, YH., Son, SH., Yoon, SC., et al.[2022]

Stereotactic body radiation therapy (SBRT) using the CyberKnife system showed a high local control rate of 89.8% for hepatocellular carcinoma (HCC) at 1 and 2 years, indicating its efficacy in managing liver-confined tumors.

Higher doses of radiation improved local control, while elevated alpha-fetoprotein (aFP) levels were linked to poorer outcomes, suggesting that treatment strategies may need to be adjusted based on aFP levels and Child-Pugh scores for better overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for hepatocellular carcinoma: prognostic factors of local control, overall survival, and toxicity. Bibault, JE., Dewas, S., Vautravers-Dewas, C., et al.[2022]

Stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer was found to be safe, with no severe treatment-related toxicities (grade 3 or higher) reported among 44 patients over a median follow-up of 40 months.

The treatment showed excellent efficacy, with a 100% cause-specific survival rate and progression-free survival rate, and a high biochemical failure-free rate of 90.8% for high-risk patients, particularly with the 34 Gy in 4 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic body radiation therapy for localized prostate cancer. Kang, JK., Cho, CK., Choi, CW., et al.[2022]

Cyberknife stereotactic body radiation therapy (SBRT) demonstrated a 2-year overall survival rate of 64.0% in patients with recurrent hepatocellular carcinoma (HCC), significantly better than the 42.1% survival rate in matched controls not receiving SBRT.

The treatment was found to be safe, with only mild and tolerable acute toxicities, indicating that SBRT is an effective option for improving survival in patients with unresectable HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy in recurrent hepatocellular carcinoma. Huang, WY., Jen, YM., Lee, MS., et al.[2022]

References

1. 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]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

[An experience of cyberknife treatment in patients with advanced pancreaticobilliary malignancy]. [2019]

3. France pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. [2018]

4. Australia pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]

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

Stereotactic body radiation therapy for hepatocellular carcinoma: prognostic factors of local control, overall survival, and toxicity. [2022]

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

Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]

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

Stereotactic body radiation therapy in recurrent hepatocellular carcinoma. [2022]