Adaptive Radiation Therapy for Pancreatic Cancer

Overseen By Joshua Meyer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: Metastatic disease, Prior radiation, Adenosquamous carcinoma, others

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

Compensation: Varies

Number of Visits: 5

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Adaptive Radiation Therapy (ART) to determine its safety and effectiveness in treating individuals with locally advanced pancreatic cancer that cannot be surgically removed. The study aims to assess whether ART can more precisely target aggressive cancer cells while sparing healthy tissue and reducing treatment side effects. Participants will receive five radiation treatments over two weeks and undergo CT scans and blood sample collection to aid in planning and monitoring the treatment. This trial suits those diagnosed with pancreatic cancer that cannot be surgically removed and who have not previously received radiation for this condition. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future cancer treatments.

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

The trial requires that you stop chemotherapy at least 2 weeks before starting the radiation therapy. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

What prior data suggests that Adaptive Radiation Therapy is safe for treating pancreatic cancer?

Research has shown that Adaptive Radiation Therapy (ART) is generally safe for treating pancreatic cancer. Some studies report that patients tolerate ART well, experiencing few severe side effects. For instance, one study found that ART posed a low risk of causing serious problems. Another study highlighted that ART is effective and safe in everyday medical settings, yielding positive results for patients. Overall, this evidence suggests that ART effectively targets cancer cells while protecting healthy tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Adaptive Radiation Therapy is unique because it customizes radiation doses in real time based on the patient's anatomy and tumor changes. Current treatments for pancreatic cancer, like standard radiation therapy, often use a fixed plan that doesn't adapt to changes in the tumor or surrounding organs over time. Researchers are excited about this treatment because it has the potential to improve precision and effectiveness, minimizing damage to healthy tissues and potentially enhancing outcomes for patients.

What evidence suggests that Adaptive Radiation Therapy is effective for pancreatic cancer?

Research has shown that Adaptive Radiation Therapy (ART) can greatly improve outcomes for patients with advanced pancreatic cancer. Studies have found that this treatment targets the tumor with high doses of radiation, even when it's near vital organs. This precision helps protect healthy tissue and reduces side effects. In this trial, participants will receive ART, which has been associated with longer average survival—about 26 months—compared to the usual 12-15 months with standard chemotherapy. Additionally, ART has been linked to better overall survival and surgery rates, suggesting it could be an effective option for treating this challenging condition. ^{3 6 7 8 9}

Who Is on the Research Team?

Joshua Meyer, MD

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with locally advanced pancreatic cancer that cannot be removed by surgery. Participants must be able to undergo CT scans, have markers placed in or near the tumor, provide a tissue sample from their cancer, and give blood samples before, during, and after radiation treatments.

Inclusion Criteria

I am a postmenopausal woman who has not had a period or breastfed in the last 12 months.

My pancreatic cancer cannot be removed by surgery.

I started chemotherapy before radiation, with my last chemo dose at least 2 weeks before starting ART.

Exclusion Criteria

I haven't had immunotherapy or antibody therapy in the last 28 days.

I am currently being treated for a serious infection with IV antibiotics.

My cancer is a type of pancreatic cancer called adenosquamous carcinoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo CT scans for planning, have tumor biopsies, and receive 5 radiation treatments every other day over a 2-week period

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including providing blood samples

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Radiation Therapy

Trial Overview The study is testing Adaptive Radiation Therapy (ART) to see if it can more accurately target aggressive cancer cells while sparing healthy tissue. The treatment involves five radiation sessions every other day across two weeks with careful planning using CT scans.

How Is the Trial Designed?

Group I: Single-Arm Experimental Treatment 1 Intervention

Adaptive Radiation Therapy

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10704901/

Pancreatic cancer outcome—local treatment with radiation ... Stereotactic MR-guided adaptive radiotherapy (SMART) allows delivery of ablative dose to abdomino-pelvic tumors, even when adjacent to OARs.

2. 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 ...

3. ecancer.org ecancer.org/en/news/21180-new-outcomes-data-demonstrating-prolonged-survival-for-inoperable-pancreatic-cancer-patients-presented-at-leading-radiation-oncology-meeting

New outcomes data demonstrating prolonged survival for ... Findings showed longer median survival of 26 months compared to 12-15 months typically seen in patients receiving chemotherapy and standard ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0167814024006170

Adaptive MRI-guided stereotactic body radiation therapy ... This study demonstrates that SBRT in patients with LAPC was associated with promising overall survival and resection rates.

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1040673/full

Clinical outcomes after online adaptive MR-guided ... This study presents clinical outcomes of a large, international cohort of patients with (peri)pancreatic tumors treated with online adaptive MRgRT.

6. henryford.com henryford.com/news/2022/11/smart-study

Promising Safety, Patient Outcomes Data for MRI-Guided ... Study Shows Promising Safety, Patient Outcomes Data for MRI-Guided Adaptive Radiation Therapy to Treat Pancreatic Cancer. November 21, 2022.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12562207/

First Spanish Experience with Stereotactic MR-Guided ... Conclusions: SMART is a feasible and safe treatment modality for BRPC and LAPC in real-world clinical practice. These encouraging early outcomes ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818117

Safety and Tolerability of Online Adaptive High-Field ... The findings of this study suggest that online adaptive MR-guided radiotherapy is associated with a low risk of high-grade acute toxic effects.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053429623000681

MRI-Guided Adaptive Radiation Therapy These data indicate that treatment of pancreatic cancer could benefit greatly from MRIgRT-based adaptive planning. In patients with oligometastatic disease ...