Intraoperative Radiation Therapy for Pancreatic Cancer

(PACER Trial)

Not currently recruiting at 6 trial locations
Theodore S Hong, MD profile photo
Overseen ByTheodore S Hong, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating pancreatic cancer, particularly when the cancer involves blood vessels. The focus is on using intraoperative radiation therapy during surgery. Researchers are testing this treatment to determine its effectiveness alongside standard treatments like chemotherapy and radiation. Suitable candidates have pancreatic cancer affecting blood vessels and have previously undergone chemotherapy and radiation. The goal is to determine if this approach can improve treatment outcomes for patients with this specific condition. As an unphased trial, this study offers patients the chance to contribute to pioneering research that could lead to new treatment options.

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

Research has shown that intraoperative radiation therapy (IORT) is generally safe when combined with surgery. Most patients recover well and experience only minor side effects. In one study, about 2.2% of patients experienced a more serious side effect. Another study found that 4.9% of patients developed radiation necrosis, a type of tissue damage, though this remains uncommon.

Many patients in these studies healed their surgical wounds within four weeks after receiving IORT. The treatment also effectively prevents cancer from returning in the treated area.

While these studies provide a good overview of IORT's safety, individual reactions can vary. Discuss potential risks and benefits with a healthcare provider.12345

Why are researchers excited about this trial?

Most treatments for pancreatic cancer with vascular involvement typically involve surgery followed by chemoradiation. However, this new approach, using Electron Beam Intraoperative Radiation Therapy (IORT), is different because it delivers targeted radiation directly to the tumor site during surgery. This innovative method allows for a higher dose of radiation with potentially fewer side effects on surrounding healthy tissue. Researchers are excited because this could improve precision and effectiveness, potentially enhancing outcomes for patients who have limited options with traditional treatments.

What evidence suggests that intraoperative radiation therapy is effective for pancreatic cancer?

Research has shown that intraoperative radiation therapy (IORT), which participants in this trial may receive, can effectively treat cancers. For example, one study found high survival rates over several years with IORT. In breast cancer treatment, IORT has demonstrated survival rates similar to traditional radiation methods. Although primarily studied in breast cancer, the approach is similar for pancreatic cancer. IORT delivers radiation directly to the tumor during surgery, potentially protecting healthy tissue and improving outcomes. While more research is needed, early findings suggest it could be a promising option for pancreatic cancer.16789

Who Is on the Research Team?

JW

Jennifer Wo, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults with pancreatic cancer who've completed specific chemotherapy regimens and radiation therapy. They must be in good physical condition, understand the study, and agree to use effective contraception. It's not for those with active infections, heart issues, psychiatric conditions that affect compliance, pregnant or breastfeeding women, or recent major surgery.

Inclusion Criteria

ECOG Performance Status 0-1
Previous completion of at least three (3) months of EITHER gemcitabine plus nab-paclitaxel OR FOLFIRINOX (5-fluorouracil, oxaliplatin, irinotecan and leucovorin)
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after IORT. Women who are not of childbearing potential, i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
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Exclusion Criteria

An active infection requiring systemic therapy
Evidence of disease progression or distant metastases.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive chemotherapy and external radiation therapy for 3-6 months

3-6 months

Intraoperative Radiation Therapy (IORT)

Participants undergo electron beam intraoperative radiation therapy during surgery

During surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Intraoperative Radiation Therapy

Trial Overview

The trial tests Electron Beam Intraoperative Radiation Therapy (IORT) as a potential treatment for pancreatic cancer patients with vascular involvement after they have already undergone certain chemotherapies and radiation treatments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: IORTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

IntraOp/Mobetron

Collaborator

Trials
1
Recruited
200+

Citations

Prospects and Disadvantages of Intraoperative Radiotherapy

While IORT demonstrates promising results, particularly in terms of reducing treatment duration and preserving healthy tissue, further high-quality studies are ...

Studies Show Risks and Benefits of Intraoperative ...

both radiation techniques had about the same breast cancer survival rates: 97.4% for intraoperative radiation therapy 98.1% for whole-breast ...

Long-Term Results of Intraoperative Radiation Therapy for ...

Within the median follow-up of 145 months (range, 12.8-187.1), the 5-year, 10-year, and 15-year overall survival rates were 98%, 94.7%, and 88%, respectively.

Intraoperative Radiation Therapy (IORT) for Breast Cancer

IORT has shown comparable survival rates to traditional whole-breast radiation. ightly higher risk of recurrence,

Intraoperative Radiation Therapy (IORT) for Early-Stage ...

The cumulative incidence of in-breast tumor recurrence at four years was 1.2% in patients who received intraoperative radiation and 0.95% in ...

IORT for early-stage, low-risk breast cancer

The estimated 5-year IBR risk in the entire cohort was 1.7 % (95 % CI: 0.7 %–2.8 %), decreasing to 1 % (95 % CI: 0.3 %–2.4 %) in the IORT + whole breast ...

Safety, effectiveness and economic evaluation of intra ... - PMC

5-year overall survival: 65%. For recurrences, the 5- year overall survival: 30%. IORT to reduce the incidence of local recurrences within the radiation area ...

Efficacy and Safety of Intraoperative Radiotherapy (IORT ...

DFS rates at 1 and 2 years were 99.1% (215/217) and 98.2% (213/217), respectively. Most patients (207/217) achieved wound healing within 4 weeks, with IORT dose ...

Multicentric Assessment of Safety and Efficacy ...

There was 1 grade 3 adverse event related to IORT recorded (2.2%). A 4.9% cumulative radiation necrosis rate was observed. The 1-year local control rate was 98 ...