Radiation Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two types of radiation therapy to determine which better reduces shoulder and arm problems in people with breast cancer that has spread to their lymph nodes. The treatments compared are Intensity-Modulated Radiation Therapy (IMRT) and 3-Dimensional Conformal Radiation Therapy (3DCRT), each lasting five weeks. Suitable candidates for this trial include those with a confirmed breast cancer diagnosis, who have undergone surgery such as a lumpectomy or mastectomy, and have received treatments like chemotherapy. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance future treatment options.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since patients who have received certain therapies like chemotherapy or endocrine therapy are eligible, it seems you may not need to stop those treatments.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Intensity-Modulated Radiation Therapy (IMRT) and 3-Dimensional Conformal Radiation Therapy (3DCRT) have different safety profiles for treating breast cancer. IMRT might expose a larger area to low doses of radiation, potentially increasing the risk of developing another cancer in the future. However, studies indicate that patients generally do not experience worse side effects, such as swelling, skin darkening, or pain, with IMRT compared to 3DCRT.
3DCRT has been well-studied, and one large study found no local cancer recurrences after five years. However, some patients reported moderate to severe late side effects in the normal tissues around the treatment area. Both treatments have effectively managed breast cancer, with similar success in controlling the disease.
In summary, both treatments are considered safe but have different risks and side effects. These factors are important to consider when thinking about joining a clinical trial.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because they offer advanced techniques in delivering radiation therapy for breast cancer. Intensity-Modulated Radiation Therapy (IMRT) is unique because it uses computer-controlled linear accelerators to deliver precise radiation doses to a malignant tumor or specific areas within the tumor, minimizing damage to surrounding healthy tissue. Meanwhile, 3-Dimensional Conformal Radiation Therapy (3DCRT) shapes the radiation beams to match the shape of the tumor, increasing the accuracy of treatment and potentially reducing side effects. Both methods aim to improve the precision and effectiveness of breast cancer treatment, offering hope for better outcomes with fewer complications compared to traditional radiation therapy.
What evidence suggests that this trial's treatments could be effective for reducing shoulder morbidity in lymph-node positive breast cancer?
Research has shown that Intensity-Modulated Radiation Therapy (IMRT), which participants in this trial may receive, can reduce the risk of immediate side effects compared to older methods. A review of several studies found that this therapy might lower the chance of breast cancer returning by up to 15%. Studies also suggest that IMRT could lessen certain treatment-related side effects. In contrast, 3-Dimensional Conformal Radiation Therapy (3D-CRT), another treatment option in this trial, effectively controls cancer but has a higher rate of immediate side effects. In summary, both IMRT and 3D-CRT work well for breast cancer, but IMRT may have fewer side effects.46789
Who Is on the Research Team?
Sasha Beyer, MD, PhD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for women with lymph-node positive breast cancer who've had a lumpectomy or mastectomy, possibly followed by reconstruction. They should be within 84 days post-surgery or chemotherapy, not pregnant or breastfeeding, and willing to use contraception during the study. Excluded are those with non-epithelial breast cancers, prior chest radiation, shoulder surgery on the same side as the cancer, impaired shoulder mobility unrelated to cancer surgery, active lupus/scleroderma/dermatomyositis with rash.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Patients undergo either Intensity-Modulated Radiation Therapy (IMRT) or 3-Dimensional Conformal Radiation Therapy (3DCRT) over 5 weeks
Follow-up
Participants are monitored for shoulder/arm morbidity and other outcomes at 1, 6, and 12 months, and then annually for up to 5 years
What Are the Treatments Tested in This Trial?
Interventions
- 3-Dimensional Conformal Radiation Therapy
- Intensity-Modulated Radiation Therapy
3-Dimensional Conformal Radiation Therapy is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator