Radiation Therapy for Breast Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Distant metastases, Unresected axillary disease, Prior breast carcinoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

61 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the shoulder morbidity in patients with lymph-node positive breast cancer receiving intensity modulated radiation therapy or 3-dimensional conformal radiation therapy. Intensity modulated radiation therapy may cause less shoulder/arm morbidity in patients with lymph-node positive breast cancer.

Research Team

Sasha Beyer, MD, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

History/physical examination within 60 days prior to study entry

You have been diagnosed with breast cancer through a pathology test.

Patients who have undergone either a lumpectomy or mastectomy are eligible

Exclusion Criteria

Medical, psychiatric, or other conditions that would prevent the patient from receiving the protocol therapy or providing informed consent

You have a type of breast cancer that is not the common kind.

You have had any type of breast cancer in the past, except for lobular carcinoma in situ (LCIS).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo either Intensity-Modulated Radiation Therapy (IMRT) or 3-Dimensional Conformal Radiation Therapy (3DCRT) over 5 weeks

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

5 years

Treatment Details

Interventions

• 3-Dimensional Conformal Radiation Therapy
• Intensity-Modulated Radiation Therapy

Trial Overview The study compares two types of radiation therapy: Intensity Modulated Radiation Therapy (IMRT) and 3-Dimensional Conformal Radiation Therapy (3D-CRT). It aims to determine if IMRT results in less harm to the shoulder/arm area than 3D-CRT for patients with lymph-node positive breast cancer.

Participant Groups

Group I: Arm B (3DCRT) Experimental Treatment 1 Intervention

Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.

Group II: Arm A (IMRT) Experimental Treatment 1 Intervention

Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.

3-Dimensional Conformal Radiation Therapy is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in European Union as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Canada as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Japan as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in China as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Approved in Switzerland as 3D-CRT for:

• Various types of cancer, including gynecologic cancers

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+