Single vs Multiple Fraction Radiotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two methods of delivering radiation therapy to women who have undergone a lumpectomy for breast cancer. It seeks to determine whether a single large dose of radiation (Single Fraction Partial Breast Irradiation, PBI) is as effective and safe as multiple smaller doses (Multiple Fraction Partial Breast Irradiation, PBI). The researchers aim to assess if the single treatment can reduce time and travel for patients without compromising care. Women who have had breast cancer surgery, with a tumor under 3 cm, may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could simplify and enhance patient care.
Do I have to stop taking my current medications for this 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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that both single-session and multiple-session partial breast irradiation (PBI) are well-tolerated treatments for breast cancer. Research indicates that multiple-session PBI, administered in five daily doses, has side effects similar to other treatment schedules. Patients have reported minimal short-term and long-term side effects, making it a reliable option for early-stage breast cancer.
Recent findings suggest that single-session PBI is also well-tolerated. This method delivers the entire radiation dose in one session. Patients have experienced minimal side effects, and the treatment has shown promising early results in controlling cancer. Both treatment types aim to limit exposure to healthy tissues, reducing side effects.
Overall, available evidence considers both methods safe. Participants in prior studies tolerated the treatments well, with side effects generally mild.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these radiotherapy treatments for breast cancer because they offer more flexible and potentially less burdensome options compared to conventional whole-breast irradiation. Unlike standard treatments that often involve multiple weeks of daily sessions, the Multiple Fraction Partial Breast Irradiation (PBI) delivers radiation in just five daily doses. Meanwhile, the Single Fraction PBI is even more streamlined, requiring just one session with a precise 13 Gy dose. These approaches could significantly reduce treatment time and increase convenience for patients, while maintaining effectiveness.
What evidence suggests that this trial's treatments could be effective for breast cancer?
This trial will compare Single Fraction Partial Breast Irradiation (PBI) with Multiple Fraction PBI for treating early-stage breast cancer. Studies have shown that Multiple Fraction PBI, delivered over five treatment sessions, effectively prevents cancer recurrence, with about 91.8% of patients remaining cancer-free after 10 years. Meanwhile, researchers are exploring Single Fraction PBI, which involves just one treatment session, as a more convenient option. Early results suggest it controls cancer effectively and is easy for patients to tolerate. Both methods aim to target the tumor area while limiting exposure to healthy tissue, helping to reduce side effects.24678
Who Is on the Research Team?
Robert Olson, MD, MSc, FRCPC
Principal Investigator
BC Cancer - Prince George
Are You a Good Fit for This Trial?
This trial is for women aged 40 or older with early-stage breast cancer (tumor less than 3 cm, no lymph node spread) who have had a lumpectomy. Participants must be able to give consent, move independently or with help, and tolerate the treatment setup.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Partial Breast Irradiation (PBI) either in a single fraction or multiple fractions
Follow-up
Participants are monitored for safety, effectiveness, and quality of life after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Multiple Fraction Partial Breast Irradiation (PBI)
- Single Fraction Partial Breast Irradiation (PBI)
Trial Overview
The study compares two ways of giving partial breast radiation after surgery: one group gets all their treatment in a single session, while the other receives it over several sessions. The goal is to see if fewer treatments are just as effective and more convenient.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
For participants randomized to Arm 2, PBI will be delivered in a single fraction with a dose of 13 Gy.
For participants randomized to Arm 1, PBI will be delivered with a dose of 26 Gy in 5 daily fractions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
British Columbia Cancer Agency
Lead Sponsor
Citations
Partial Breast Irradiation
Mature results of single fraction elderly breast irradiation (SiFEBI) trial confirmed 5-year locoregional-free survival and OS rates of 100% and 88.5%, ...
2.
consultqd.clevelandclinic.org
consultqd.clevelandclinic.org/partial-breast-irradiation-delivered-daily-well-tolerated-in-patients-with-early-stage-breast-cancerStudy compares treatment schedules for partial breast irradiation
Research found five-fraction partial breast irradiation therapy has similar acute and late toxicity with daily and every other day treatment ...
Long-term outcomes of three distinct once-daily schedules ...
Once-daily APBI delivered with 3D-conformal radiotherapy was effective; however, regimens with fewer than 5 fractions may be associated with ...
Seven fractions to deliver partial breast irradiation - PMC - NIH
7 daily fractions is an effective and well-tolerated regimen to deliver PBI. es-free survival rate of 96.7%. 5-year overall survival was 98.5%.
A Meta-Analysis of Trials of Partial Breast Irradiation
The results of recent trials of PBI compared with whole breast irradiation (WBI) have suggested conflicting results with respect to local control and toxicity.
Phase II single vs hypofractionated irradiation for timely ... - PMC
Multiple studies with extensive follow-up periods have demonstrated the comparative efficacy and toxicity outcomes of partial breast irradiation ...
Comparison of Acute and Late Toxicities With Daily Versus ...
Overall, 5-fraction PBI delivered daily appears to be well tolerated with similar acute and chronic toxicity to every other day fractionation.
8.
springermedizin.de
springermedizin.de/seven-fractions-to-deliver-partial-breast-irradiation-the-toxici/12309984Seven fractions to deliver partial breast irradiation
In conclusion, we showed that a 7 fractions schedule for PBI is safe, although a longer follow-up is needed to further ascertain late toxicity, and in ...
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