Intraoperative Radiation Therapy for Pancreatic Cancer
(PACER Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy
Participants receive chemotherapy and external radiation therapy for 3-6 months
Intraoperative Radiation Therapy (IORT)
Participants undergo electron beam intraoperative radiation therapy during surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
* IORT will be administered as determined to be best practice by the treating radiation oncologist, * Electron beam intraoperative radiation therapy will occur in a hybrid operating room with a portable linear accelerator
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
IntraOp/Mobetron
Collaborator
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.
4.
saintjohnscancer.org
saintjohnscancer.org/breast/breast-cancer/treatment/intraoperative-radiation-therapy-iort-for-breast-cancer/Intraoperative Radiation Therapy (IORT) for Breast Cancer
IORT has shown comparable survival rates to traditional whole-breast radiation. ightly higher risk of recurrence,
5.
connection.asco.org
connection.asco.org/do/intraoperative-radiation-therapy-iort-early-stage-breastIntraoperative 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 ...
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