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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Cyberknife, a form of stereotactic body radiation therapy, for individuals with Stage I to Stage III pancreatic cancer. The researchers aim to determine if Cyberknife can shrink tumors enough to make them removable and improve quality of life compared to IMRT, another type of radiation therapy. Participants will receive Cyberknife in five sessions over one to two weeks, or they might receive IMRT, which involves 28 sessions over five and a half weeks. Ideal candidates have completed chemotherapy and have pancreatic cancer that cannot currently be surgically removed but might be if the tumor shrinks. As an unphased trial, this study provides a unique opportunity to explore an innovative treatment option that could potentially enhance quality of life.

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 prior data suggests that the Cyberknife System is safe for treating pancreatic cancer?

Previous studies have tested Cyberknife, a type of precise radiation therapy, for safety in treating pancreatic cancer. Research has shown that Cyberknife is generally well-tolerated. Side effects are usually mild and may include tiredness or nausea, common with many cancer treatments. Importantly, serious side effects are rare. For patients with pancreatic cancer, Cyberknife has shown promising results in managing the disease with manageable safety concerns. This information may help prospective trial participants feel more informed about the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cyberknife for pancreatic cancer because it offers a precise and targeted delivery of radiation therapy in fewer sessions compared to traditional methods. Unlike standard treatments like Intensity-Modulated Radiation Therapy (IMRT), which requires daily sessions over several weeks, Cyberknife delivers higher doses in just five sessions over one to two weeks. This not only reduces the overall treatment time but also minimizes exposure to surrounding healthy tissues, potentially leading to fewer side effects and improved patient comfort.

What evidence suggests that Cyberknife might be an effective treatment for pancreatic cancer?

Research has shown that CyberKnife, an advanced radiation therapy, holds promise for treating pancreatic cancer. In this trial, participants will receive either CyberKnife or IMRT. Studies have found that CyberKnife effectively manages both primary and secondary pancreatic cancer by accurately targeting tumors. This approach is particularly beneficial for tumors difficult to remove surgically. Past patients demonstrated that CyberKnife can shrink tumors and sometimes enable surgery for previously inoperable cases. Additionally, CyberKnife has been associated with favorable long-term outcomes for those with localized pancreatic cancer. Overall, evidence suggests that CyberKnife could be an effective treatment option for pancreatic cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Shirnett Williamson, MD

Principal Investigator

Capital Health System, Inc

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12338085/

Investigating the Efficacy and Safety of the CyberKnife ... CyberKnife SBRT appears to be a promising treatment modality for managing primary pancreatic cancer with metastases to the gastrointestinal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4499360/

Stereotactic body radiotherapy using CyberKnife for locally ... The current research hotspot is to evaluate the efficacy and toxicity of SBRT for patients with locally advanced unresectable and metastatic pancreatic cancer.

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025052144

Long-Term outcomes of ablative stereotactic body radiation ... Original Article. Long-Term outcomes of ablative stereotactic body radiation therapy for inoperable, non-metastatic pancreatic cancer.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824000156

Stereotactic body radiotherapy for pancreatic cancer This systematic review aims to comprehensively summarize the current prospective evidence regarding Stereotactic Body Radiotherapy (SBRT) in various clinical ...

6. wjgnet.com wjgnet.com/1007-9327/full/v21/i26/8156.htm

Stereotactic body radiotherapy using CyberKnife for locally ... We investigated the outcomes in a series of patients with locally advanced unresectable and metastatic pancreatic cancer who underwent SBRT.

7. bmjopen.bmj.com bmjopen.bmj.com/content/6/12/e013220.full.pdf

Safety and efficacy of stereotactic body radiation therapy ... The SILAPANC trial aims to investigate the efficacy and adverse effects of Cyberknife with S-1 in patients with locally advanced pancreatic ...