FREQUENTLY ASKED QUESTIONS
2. What are the alternatives to Single-Day Targeted Intraoperative Radiotherapy?
3. Must I live in Los Angeles to participate in the Targit Trial?
7. What kind of follow-up is needed if I participate in the Targit Trial?
10. What are the advantages of Single-Day Targeted Intraoperative Radiotherapy?
11. What are the disadvantages of Single-Day Targeted Intraoperative Radiotherapy?
12. What are the possible side effects and risks associated with participating in the Targit Trial?
13. Can I participate in the Targit Trial if I need to receive chemotherapy or hormonal therapy?
14.. When will the results of the Targit Trial be known?
15. Will my medical information be kept private?
16.What are the costs of participating in the Targit Trial?
17. What are my rights as a participant in the Targit Trial?
19. Do I get compensated for participating in the Targit Trial?
1. Can I obtain Single-Day Targeted Intraoperative Radiotherapy without participating in the TARGIT Trial?
Single-Day Targeted Intraoperative Radiotherapy may be obtained in 2
ways:
a) as a one-day treatment given at the time of surgery immediately following
tumor removal.
- Single-Day Targeted Intraoperative Radiotherapy is currently being evaluated as an alternative to Conventional Postoperative Radiotherapy and may only be obtained by participating in the Targit Trial. Half of the participants in the Targit Trial will receive Single-Day Targeted Intraoperative Radiotherapy at the time of surgery following removal of the breast cancer. The other half will receive Conventional Postoperative Radiotherapy given over a 6-7 week period after recovering from surgery.
b) as a “boost” treatment given at the time of surgery, followed by Conventional Postoperative Radiotherapy after recovering from surgery.
- Conventional Postoperative Radiotherapy treatment for patients undergoing lumpectomy is to treat the entire breast with radiotherapy after surgery. In addition to Conventional Postoperative Radiotherapy, nearly all patients at USC also receive an additional dose of radiotherapy that is confined to the part of the breast that contained the breast cancer. The additional treatment is called a “boost” and is usually given as a daily treatment for 1 week after completing a 6-week course of Conventional Postoperative Radiotherapy. You may replace the entire 1-week “boost” by receiving the “boost” at the time of surgery. This will not only improve the accuracy or your boost radiotherapy, but also shorten your radiotherapy treatment by one week, saving you 1 week of visits to the hospital. Intraoperative radiotherapy given has a “boost” has been used for more than a decade in Europe. Studies show that it is a safe and reliable method for administering boost radiotherapy as long as it is followed by Conventional Postoperative Radiotherapy.
2. What are the alternatives to Single-Day
Targeted Intraoperative Radiotherapy?
Several alternatives to Single-Day Targeted Intraoperative Radiotherapy
are available at USC and may be administered to women not participating
in the Targit Trial. These alternatives are listed below:
Conventional Postoperative Radiotherapy. Conventional Postoperative Radiotherapy
is the standard treatment that has been used for many years for patients
undergoing lumpectomy for breast cancer. At USC, Conventional Postoperative
Radiotherapy is administered to the whole breast over a 6-week period
followed by 1 additional week of “boost” radiotherapy confined
to the part of the breast that contained the breast cancer. You may obtain
Conventional Postoperative Radiotherapy without participating in the Targit
Trial.
Mammosite Balloon Catheter Radiotherapy. Mammosite Balloon Catheter Radiotherapy is type of radiotherapy administered through a catheter (tubing) that is inserted into the breast during or after surgery. The radiation treatment is given 2 times a day for 5 days and is designed to treat only the portion of the breast that contained the breast cancer. This reduces the radiation treatment time from 6 weeks to 1 week. Mammosite Balloon Catheter Radiotherapy may be obtained without participating in the Targit Trial.
3-D Conformal Radiotherapy. 3-D ConformalRadiotherapy is a type of partial breast irradiation that is adminitered externally, using radiation that passes through the skin to enter the breast. Using 4 or 5 intersecting beams of radiation, the radiotherapy treatment is focused on the part of the breast that contained the breast cancer. This treatment is given on a daily basis for a total of 2 weeks
3. Must I live in Los Angeles to participate
in the Targit Trial?
You do not need to live in Los Angeles to participate in the Targit Trial. However, you will need to be evaluated at USC to determine if you are eligible for the Targit Trial. This evaluation will include a visit with the surgeon and radiation oncologist. Additional radiology studies (mammograms, ultrasounds, and/or breast MRI) may also be requested prior to determining your eligibility for the study.
If you qualify for the Targit Trial and are willing to participate in this study, you will be assigned to receive either Single-Day Targeted Intraoperative Radiotherapy or Conventional Postoperative Radiotherapy. If you are assigned to the Single-Day Targeted Intraoperative Radiotherapy treatment, you will need to undergo breast surgery and Intraoperative Radiotherapy at USC. If you are assigned to the Conventional Postoperative Radiotherapy treatment, you can choose to receive this treatment at USC or you may choose to receive this treatment at a hospital near your home.
Finally, regardless of where you live or which type of radiotherapy you receive, participation in the Targit Trial requires that you meet with the USC doctors every 6 months for the first 5 years, and then annually for an additional 5 years. Each participant is expected to provide her own travel and accommodations for these follow-up visits. Any medical costs associated with these follow-up visits will be billed to your insurance company or to Medicare.
During each check-up visit, you will be examined by the surgeon and radiation oncologist as well as receive mammograms and any additional needed studies. The purpose of these check-ups is to confirm that you are doing well to be evaluate you for the possibility of a breast cancer recurrence.
4. If I am assigned to receive Conventional
Postoperative Radiotherapy, must I receive the treatment at USC?
One very convenient aspect of the Targit Trial is that you will be allowed to receive Conventional Postoperative Radiotherapy at a hospital near your home if you have been assigned to that treatment. The radiation oncologist at USC will contact your community hospital to confirm that it can administer Conventional Postoperative Radiotherapy in a way that is required by the TARGIT Trial.
5. Can I participate in the Targit Trial if I have already had my breast cancer surgery (lumpectomy)?
Yes. You may still qualify for the Targit Trial if you have had a lumpectomy within the past 4 weeks for invasive breast cancer. To determine if you are eligible, you will need to be evaluated by a surgeon and radiation oncologist at USC. This evaluation will include physical examination, review of your mammograms and ultrasound, and review of your pathology results. Additional radiology studies (mammograms, ultrasounds, and/or breast MRI) may be requested prior to determining your eligibility for the study. If you are allowed to participate in the Targit Trial, you will be randomly assigned to receive either Single-day Targeted Intraoperative Radiotherapy or Conventional Postoperative Radiotherapy. If you are assigned to the Single-day Targeted Intraoperative Radiotherapy treatment, you will need to undergo one additional breast operation so that this treatment may be given to you. On the other hand, if you are assigned to the Conventional Postoperative Radiotherapy treatment, you will receive this treatment over a 6-7 week period after you have recovered from surgery. You may obtain this Conventional Postoperative Radiotherapy at USC or at a hospital near your home.
6. If I have already had breast cancer surgery (lumpectomy), how will your pathology results influence your participation in the Targit Trial?
If you have already had a lumpectomy, your pathology results and slides
will need to be reviewed at USC to determine if you qualify for participation
in the Targit Trial. Based on your pathology results, there are 3 possible
scenarios:
Scenario #1:
Your pathology report and slides will be acceptable and
you may then be enrolled in the Targit Trial.
xxxa. If you are assigned to the Single-Day
Targeted Intraoperative Radiotherapy treatment, you will need to undergo
an additional operation under general anesthesia so that this treatment
may be given to you in the operating room. At the time you receive this
treatment, the surgeon will need to temporarily reshape your breast tissue
so that Intraoperative Radiotherapy may be given properly.
xxxb. If you are assigned to the Conventional
Postoperative Radiotherapy treatment, you will receive this treatment
after recovering from surgery. You may receive Conventional Postoperative
Radiotherapy at USC or at a hospital near your home.
Scenario #2:
Your pathology report and slides will indicate that Single-Day
Targeted Intraoperative Radiotherapy is not appropriate for you as the
sole radiotherapy treatment for your breast cancer. Therefore, you cannot
participate in the Targit Trial. If this happens, you will have three
radiotherapy options:
xxxOption #1:
Conventional Postoperative Radiotherapy given over a 6-7 week
period after you have recovered from surgery
xxxOption #2:
Partial Breast Radiotherapy given by Mammosite Balloon Catheter Radiotherapy
given over 5 days or 3-D Conformal Radiotherapy given over 14 days.
xxxOption #3:
Intraoperative Radiotherapy given as a “boost” treatment
at the time of surgery to be followed by Conventional Postoperative Radiotherapy
given to the remaining breast after you have recovered from surgery. Receiving
your “boost” treatment in the operating room will reduce your
Conventional Postoperative Radiotherapy treatment by 1 week.
Scenario #3:
Your pathology report and slides may indicate that you will need to have
additional breast tissue removed in order to participate in the Targit
Trial.
xxxa. If you are assigned to receive Single-day
Targeted Intraoperative Radiotherapy, the radiotherapy treatment will
be administered during surgery after additional breast tissue has been
removed.
xxxb. If you are assigned to the Conventional
Postoperative Radiotherapy treatment, you will first undergo removal of
additional breast tissue then receive Conventional Postoperative Radiotherapy
after you have recovered from surgery.
7. What kind of follow-up is needed if I participate in the Targit Trial?
Regardless of where you live or which type of radiotherapy you receive, participation in the TargitTrial requires that you meet with the USC doctors every 6 months for the first 5 years, and then annually for an additional 5 years. Each participant is expected to provide her own travel and accommodations for these follow-up visits. Any medical costs associated with these follow-up visits will be billed to your insurance company or to Medicare. If you plan to move and will no longer be able to return to USC for follow-up, if is important that you notify your doctors at USC so that they can maintain contact with you and your new doctors.
8. What happens if I have received Single-day
Targeted Intraoperative Radiotherapy, but after surgery my pathology results
show that my breast cancer has not been adequately removed?
If you have received intraoperative radiotherapy but are found to have an inadequately removed breast cancer, the surgeon might advise you that you need to undergo additional breast surgery. If the surgeon believes that you can successfully undergo a second lumpectomy, you will undergo a second operation but you will not be given intraoperative radiotherapy a second time. Instead, you will be advised to receive whole breast radiotherapy after recovering from surgery.
To maximize the chance that your initial surgery will be successful, the surgeon and radiation oncologist will use a range of studies to understand the nature and full extent of your cancer prior to going into surgery. This will greatly improve the chances of successful initial surgery.
9. Will I have the option of having breast cancer surgery (lumpectomy) first then intraoperative radiotherapy as a second procedure after I have received my pathology reports?
Although most patients who are chosen to receive intraoperative radiotherapy will receive intraoperative radiotherapy at the time of their first operation, some patients might choose to receive and discuss their pathology results prior to receiving intraoperative radiotherapy. This approach will prevent intraoperative radiotherapy from being given needlessly if the pathology results reveal that the tumor has not been adequately removed and that more surgery is needed. The TargitTrial permits intraoperative radiotherapy to be given only once. Therefore, a woman who receives intraoperative radiotherapy during the first operation who then undergoes a second operation to the same part of that breast will not be given intraoperative radiotherapy a second time. Instead, after recovering from surgery, she will need to undergo Conventional Postoperative Radiotherapy.
To maximize the chance that your initial surgery will be successful, the surgeon and radiation oncologist will use a range of studies to understand the nature and full extent of your cancer prior to going into surgery. This will greatly improve that your first operative will be successful, thus minimizing the need for repeat surgery.
10. What are the advantages of Single-Day
Targeted Intraoperative Radiotherapy?
The principal advantage of Single-Day Targeted Intraoperative Radiotherapy is the ability to administer the entire therapeutic dose of breast radiotherapy at the time of surgery while you are under anesthesia. This allows a woman to complete her breast cancer therapy sooner, permitting a quicker return to her normal life. For women not needing chemotherapy, this means that almost her entire breast cancer therapy can be completed in a single day. Daily oral endocrine therapy would be the only treatment remaining. The end result would be greatly enhanced feasibility of breast conservation therapy for some women who otherwise might be pressed to choose mastectomy.
Another benefit of Single-Day Targeted Intraoperative Radiotherapy is the ability of the surgeon and radiation oncologist to target the radiotherapy treatment to the breast tissues at greatest risk of a breast cancer recurrence. This avoids the possibility of a “geographical miss” that sometimes occurs with Conventional Postoperative Radiotherapy. Because of the potential for “geographic miss”, the radiation oncologist normal request that you obtain several pre-treatment x-rays and scans so that they can properly plan your treatment. Since Targeted Intraoperative Radiotherapy is given directed into the lumpectomy cavity, this treatment completely avoids the possibility of geographical miss. Focusing the radiotherapy treatment to the breast tissues immediately surrounding the lumpectomy cavity has the additional benefit if sparing nearby normal tissues (breast, skin, chest wall and shoulder) of the effects of radiation.
11. What are the disadvantages of Single-Day Targeted Intraoperative Radiotherapy?
The principle disadvantage of Single-Day Targeted Intraoperative Radiotherapy is that this treatment is still under investigation as an alternative to Conventional Postoperative Radiotherapy. Although the risk of breast cancer recurrence within the first 5 years after treatment appears to be equally low for Single-Day Targeted Intraoperative Radiotherapy and Conventional Postoperative Radiotherapy, more research is needed to determine if the breast cancer recurrence rate will remain low in the Single-Day Targeted Intraoperative Radiotherapy group.
Since Single-Day Targeted Intraoperative Radiotherapy treats only a portion of the breast, a theoretical disadvantage for this treatment is the potential for an increased chance of breast cancer recurrence in the portions of the breast that are not treated with radiotherapy. To minimize the chances of a breast cancer recurrence, the Targit Trial will only enroll women who have a low risk of breast cancer recurrence.
A third principle disadvantage of Single-Day Targeted Intraoperative Radiotherapy is that the radiotherapy treatment is given at the time of surgery, before the final results of your pathology is known. If your pathology results indicate that you will need additional breast surgery, you will not be permitted to receive Targeted Intraoperative Radiotherapy again. Therefore, you initial Targeted Intraoperative Radiotherapy treatment might have been wasteful. Therefore, you will have to receive Conventional Postoperative Radiotherapy after recovering from surgery. To maximize the chance that your initial surgery will be successful, the surgeon and radiation oncology will use a range of studies tounderstand the nature and full extent of your cancer prior to going into surgery. This will greatly improve the chances of successful initial surgery.
12. What are the possible side effects and
risks associated with participating in the Targit Trial?
Side Effects and Risks Related to Surgery: Side effects and risks related to breast cancer surgery are similar to any cancer removal surgery: infection, bleeding, loss or reduced nerve function, swelling (edema), blood clotting, hematoma (accumulation of blood within the wound), seroma (accumulation of fluid within the wound), wound breakdown, bruising, scarring, and allergic reactions. If severe, these complications may require that you be admitted to the hospital or possibly undergo additional surgery. You may also need to undergo additional breast surgery if your first operation does not adequately remove the cancer.
Side Effects and Risks Related to Conventional Postoperative Radiotherapy: Conventional Postoperative Radiotherapy may cause redness and soreness of the skin of the breast, tenderness or painful sensations within the breast, feeling sick (nausea) and tiredness. These side effects gradually disappear once your course of treatment has finished, but may also continue for several months. Complications arising from Conventional Postoperative Radiotherapy include infection, loss or impairment of nerve function, swelling (edema), scarring, rib fracture, chest wall pain, skin ulceration and radiation induced tissue death. Scarring may be a long-term complication of radiotherapy and some firmness, tenderness, pain or deformity in the treated area of the breast may develop in the future. Some of these treatments may limit the ability of physical examination and mammograms to evaluate your breast for a cancer recurrence and may require that you undergo additional studies to evaluate your breast.
Side Effects and Risks Related to Single-day Targeted Intraoperative Radiotherapy: Single-Day Targeted Intraoperative Radiotherapy may cause redness and soreness of the skin of the breast, tenderness or painful sensations within the breast, feeling sick (nausea) and tiredness. These side effects gradually disappear once your course of treatment has finished, but may also continue for several months. Complications arising from Single-Day Targeted Intraoperative Radiotherapy include loss or impairment of nerve function, swelling (edema), scarring, chest wall pain, skin ulceration, radiation induced tissue death, and delayed wound healing. Scarring may be a long-term complication and some firmness, tenderness, pain or deformity in the treated area of the breast may develop in the future. Some of these treatments may limit the ability of physical examination and mammograms to evaluate your breast for a cancer recurrence and may require that you undergo additional studies to evaluate your breast. Since Single-day Targeted Intraoperative Radiotherapy is given to only a portion of the breast, there is a risk that the untreated portions of the breast will be at greater risk of developing a breast cancer recurrence. For your protection, your doctors will make every reasonable effort to ensure that you are a good candidate for Single-day Targeted Intraoperative Radiotherapy.
You may experience no side effects, some of them or most of them. Although
you will be closely monitored, not all side effects can be predicted and
unforeseen problems can arise. There may be some unknown or unanticipated
risks or discomforts in addition to those specified above.
Side Effects and Risks Related to Chemotherapy: If chemotherapy is needed
to treat your cancer, some patients undergoing chemotherapy after first
receiving radiotherapy may experience a skin reaction consisting of redness,
blistering, or peeling of the skin of the breast. These side effects are
usually mild and usually heal in a few weeks, but these side effects may
sometime require treatment with oral or skins medications. Since Single-day
Targeted Intraoperative Radiotherapy is given at the time of surgery,
before chemotherapy, a skin reaction may be associated with this treatment.
Risk Related to Pathology: If you have received Single-Day Targeted Intraoperative Radiotherapy at the time of surgery, but are found after surgery to have a tumor greater than 3 centimeters (1-1/8 inches), extensive non-invasive cancer (DCIS), or cancer involving your lymph nodes, you will be advised to undergo Conventional Postoperative Radiotherapy in spite of having already received Single-Day Targeted Intraoperative Radiotherapy. If your pathology results reveal that the tumor has been incompletely removed, you will be advised to undergo additional surgery followed by Conventional Postoperative Radiotherapy.
Risk of Breast Cancer Recurrence: Regardless of the type of radiotherapy you receive, there is a risk that cancer might recur in your breast. Since Single-Day Targeted Intraoperative Radiotherapy treats only a portion of the breast, theoretically, there is a increased chance of breast cancer recurrence in the portions of the breast that are not treated with radiotherapy. Although the risk of breast cancer recurrence within the first 5 years after treatment appears to be equally low for Single-Day Targeted Intraoperative Radiotherapy and Conventional Postoperative Radiotherapy, more research is needed to determine if the breast cancer recurrence rate will remain similar between the two treatments. To minimize the chances of a breast cancer recurrence, the Targit Trial will be limited to women who have a low risk of breast cancer recurrence.
13. Can I participate in the Targit Trial
if I need to receive chemotherapy or hormonal therapy?
Most women with breast cancer are advised to take chemotherapy or endocrine treatment to try to stop the cancer from coming back. Participation in the Targit Trial will not prevent you from receiving these treatments, nor will it interfere with the type, timing, and dosage of these treatments. If you have been assigned to receive Intraoperative Radiotherapy and have also been advised to receive chemotherapy, your chemotherapy treatment may be started as soon as your medical oncologist is ready to treat you. If you have been assigned to receive Conventional Postoperative Radiotherapy, chemotherapy may be started soon after you have recovered from surgery, and then will be followed by Conventional Postoperative Radiotherapy after you have completed chemotherapy. Finally, if you have been advised to receive endocrine therapy (for example, Tamoxifen or Arimidex), this treatment is usually started after you have completed chemotherapy and radiotherapy.
14. When will the results of the Targit Trial be known?
The results of the Targit Trial may not be analyzed for several years, following strict scientific guidelines as to when this should be done. Until then, the data from the study will be regularly reviewed by a small group of international experts not directly involved in the study (called the Data Monitoring and Safety Committee). They will advise and make recommendations on the safety and conduct of the study. They are independent and ensure that the study is run to the highest ethical and scientific standards.
When the results have been analyzed, your doctor will be informed so that he can pass on the information to you. A paper will also be published in a scientific journal so that doctors all over the world can read the results. Individual patients will not be identifiable from the information in any publication.
15. Will my medical information be kept private?
Every effort will be made by the investigators to maintain the confidentiality of your medical records. However, we cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. Specific study-related information will be made available to Zeiss, Inc., the manufacturer of the Intraoperative Radiotherapy equipment. For safety reasons, the Food and Drug Administration (FDA) will be allowed access to your medical records. Unless required by law, the FDA will maintain the confidentiality of your medical records. If results of this study are published in medical literature, you will not be identified by name. With your permission, medical information will be provided to your insurance company or Medicare.
16.What are the costs of participating in
the Targit Trial?
After you have been assigned to one of the two treatments, USC will contact your insurance company or Medicare to determine if it will pay for your treatments. If your insurance company or Medicare refuses to pay for your treatments, you may only participate in the Targit Trial if you are willing and able to pay for the treatments yourself. USC will inform you of all associated costs prior to your making a final decision to participate in the Targit Trial. The doctors are willing to help you obtain payment authorization from your insurance company or Medicare.
17. What are my rights as a participant
in the Targit Trial?
Your participation in the Targit Trial is voluntary. Your decision whether or not to take part will not affect your current or future care at USC. You are not waiving any legal claims or rights. If you do decide to take part in this study, you are free to change your mind and stop being in the study at any time.
Whom do I call if I have a question about or problems related to the
Targit Trial?
If you have any questions about or problems related to the Targit Trial,
you should contact the Principal Investigator, Dr. Dennis Holmes, at 323-865-3933
or targittrial@surgery.usc.edu.
If you have any questions about your rights as a study participant, you
may contact the Institutional Review Board Office at LAC+USC Medical Center,
IRD Building, 2020 Zonal Ave., Suite 425, Los Angeles, CA 90033 (Telephone
number: 323-223-2340). You may also receive a copy of the Informed
Consent statement, a Targit
Trial Patient DVD, or the Targit
Trial Patient Brochure.
18. Does my patient get compensated for participation in the Targit Trial?
No. There is no payment given to your patient for particpating in the Targit Trial
19. Do I get compensated for participating in the Targit Trial?
No. There is no compensation given for your participation in the Targit Trial.
