OBTAINING SINGLE-DAY TARGETED INTRAOPERATIVE RADIOTHERAPY

The USC Norris Comprehensive Cancer Center is one of only a few cancer centers internationally where Single-Day Targeted Intraoperative Radiotherapy is offered. This treatment may be obtained through participation in an international clinical trial called the Targit Trial. The goal of the trial is to compare Single-Day Targeted Intraoperative Radiotherapy given at the time of breast cancer surgery to Conventional Postoperative Radiotherapy given over a 6-7 week period after surgery.

There are 4 steps to determining who receives Single-Day Targeted Intraoperative Radiotherapy or Conventional Postoperative Radiotherapy.

1. Determination of Eligibility: Prior to joining the study, you must meet with study investigators at USC to determine if you qualify for the Targit Trial. This evaluation will include a physical examination, review of your mammograms and ultrasounds, and review of your pathology results. Additional radiology studies (mammograms, ultrasounds, and/or breast MRI) may also be requested prior to determining your eligibility for the study.

In order to participate in the Targit Trial, the following criteria must be met:

You must be age 40 or older.
You must have invasive (also called infiltrating) breast cancer.
You must have a breast cancer measuring 3 centimeters (1-1/8 inches) or less.
You must have a breast cancer treatable with lumpectomy.
You must be capable of receiving breast radiotherapy (not pregnant, no history of previous radiotherapy to the same breast, no connective tissue disorder).

The following factors will disqualify you from participating in the Targit Trial:

You have multiple areas of cancer within your breast.
You have cancer in both of your breasts.
Your diagnostic biopsy shows extensive non-invasive cancer (DCIS or Ductal Carcinoma in situ).
Your lymph nodes contain cancer metastasis.

2. Informed Consent: If you qualifying for the Targit Trial, you will be given an Informed Consent statement that clearly describes important aspects of the Targit Trial, including the benefits and risks of the different treatments. The trial investigators will review the Informed Consent statement with you, answer any questions that you have, and request that you sign the Informed Consent statement to confirm your willingness to participate in the Targit Trial. By signing the Informed Consent statement, you indicate that you are interested in participating in the TARGIT Trial and that you are willing to receive whichever treatment assigned to you.

3. Randomization: After signing the Informed Consent statement, a computer that will randomly assign one of the two treatments to you in a process similar to flipping a coin. Half of the participants will receive Single-Day Targeted Intraoperative Radiotherapy and half will receive Conventional Postoperative Radiotherapy. To ensure the integrity of the study, neither you nor your doctors will be permitted to determine which treatment you will receive.

4. Scheduling of Surgery: After treatment has been determined, you, the surgeon, and the radiation oncologist will schedule the date of your operation. If you have been assigned to receive Single-Day Targeted Intraoperative Radiotherapy, you will receive Targeted Intraoperative Radiotherapy at the time of your breast cancer surgery while you are still under anesthesia. The radiotherapy treatment will take between 20 and 35 minutes, depending on the size of your breast cancer and will add approximately 45 minutes to the length of the operation. On the other hand, if you have been assigned to receive Conventional Postoperative Radiotherapy, you will receive Conventional Postoperative Radiotherapy over a 6-7 week period after you have recovered from breast surgery.