Intraoperative Radiotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies a treatment called Intraoperative Radiation Therapy (IORT) for women with early-stage breast cancer. The goal is to assess the safety and effectiveness of IORT during breast-conserving surgery, which aims to remove cancer while preserving as much of the breast as possible. Researchers will monitor patient outcomes, including side effects, cancer recurrence, and overall health. Women with a single breast cancer tumor smaller than 3 cm who are scheduled for a partial mastectomy may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in breast cancer care.
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 this treatment method is safe for women with early stage breast cancer?
Research has shown that Intraoperative Radiation Therapy (IORT) is generally safe for patients with early-stage breast cancer. Studies have found that skin reactions are usually milder with IORT compared to traditional external radiation. However, long-term effects like breast fibrosis, where the breast tissue becomes hard, can occur.
Patients have often tolerated IORT well. It has been used successfully in real-world clinical settings, with most patients not experiencing severe side effects. This treatment targets radiation directly to the area where the tumor was removed, reducing exposure to healthy tissue.
While no treatment is without risk, current evidence supports the safety of IORT for many women with early-stage breast cancer. Patients should always discuss potential risks and benefits with their doctor before deciding on a treatment.12345Why are researchers excited about this trial?
Intraoperative Radiation Therapy (IORT) is unique because it delivers radiation directly to the tumor site during surgery, unlike traditional radiation therapy, which often involves multiple sessions over several weeks. This method provides a concentrated dose of radiation right after the tumor is removed, potentially reducing the overall treatment time and sparing healthy surrounding tissue from exposure. Researchers are excited about IORT because it could lead to faster recovery times and fewer side effects, offering a more convenient and patient-friendly approach for those undergoing breast-conserving surgery for early-stage breast cancer.
What evidence suggests that Intraoperative Radiation Therapy (IORT) is effective for early stage breast cancer?
Research has shown that intraoperative radiation therapy (IORT), which participants in this trial may receive, effectively treats early-stage breast cancer. Studies have found that IORT offers similar results to traditional whole-breast radiation therapy but with milder side effects, such as skin irritation. Patients receiving IORT experience fewer long-term issues, like breast hardening, compared to those undergoing external beam radiation therapy. In real-world situations, IORT has successfully controlled cancer with low recurrence rates. Overall, it presents a promising option for patients seeking efficient and convenient treatment.12346
Who Is on the Research Team?
Janie Grumley, MD
Principal Investigator
John Wayne Cancer Institute, Providence Saint John's Health Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Intra-Operative Radiotherapy
Participants undergo partial mastectomy and receive intra-operative radiotherapy (IORT)
Follow-up
Participants are monitored for short and long-term outcomes, including perioperative complications and disease recurrence
Long-term Follow-up
Participants are monitored for disease-specific and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Intraoperative Radiation Therapy (IORT)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants who plan to undergo partial mastectomy for treatment of early stage breast cancer will be considered for eligibility for IORT. Patient with single breast cancer less than 3cm in disease span, clinical negative axillary node will be offered the option of having IORT. If IORT is delivered following surgical resection of the tumor they will be followed in this registry for short and long term outcomes.
Intraoperative Radiation Therapy (IORT) is already approved in United States, European Union for the following indications:
- Cervical cancer
- Colorectal cancer
- Soft tissue sarcoma
- Uterine cancer
- Breast cancer
- Pancreatic cancer
- Colorectal cancer
- Uterine cancer
- Breast cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
John Wayne Cancer Institute
Lead Sponsor
Saint John's Cancer Institute
Lead Sponsor
Citations
Intraoperative Radiation Therapy (IORT) for Breast Cancer
IORT is extremely convenient for the patient and offers many advantages when compared with other methods of partial or whole breast treatment.
IORT for early-stage, low-risk breast cancer
This study reports on oncological outcomes in a real-world clinical setting and contributes to the understanding of its optimal indication.
3.
breast-cancer-research.biomedcentral.com
breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-024-01936-0Intraoperative radiotherapy versus ... - Breast Cancer Research
We aimed to compare the outcome of IORT to that of whole-breast external beam radiotherapy (EBRT) in highly selected breast cancer patients.
ASTRO corrects media misinformation on breast cancer ...
While acute skin toxicity is less severe with IORT compared to external beam radiation, long-term toxicity such as breast fibrosis is ...
Long-Term Results of Intraoperative Radiation Therapy for ...
To present the long-term results of intraoperative radiation therapy (IORT) for early breast cancer using a nondedicated linear accelerator.
Long‑term follow‑up outcomes of intraoperative ...
The current study was a retrospective cohort study exploring the efficacy, safety and cosmetics of IORT in patients with early-stage breast ...
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