Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | March 11, 2014 |
| End Date: | March 2019 |
Phase II Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions
The purpose of this study is to determine if a radiation treatment called "Multi-beam
Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant
if they are a candidate for radiation therapy. Currently, the standard method of giving
radiation is with "3D radiation", which only uses 2-5 beams of radiation. "Multi-beam" IMRT
works by using 8-12 small radiation beams to give a more "tailored" or "customized" radiation
dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT
may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is
to reduce complications after irradiation to the implants.
The study doctors have recently completed a trial using this technique and are now
specifically looking at its impact on women with implant reconstructions who are undergoing
post-mastectomy radiation therapy. By delivering a more "customized" dose of radiation to the
implant, the intent is to reduce side effects of radiation on the implant.
Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant
if they are a candidate for radiation therapy. Currently, the standard method of giving
radiation is with "3D radiation", which only uses 2-5 beams of radiation. "Multi-beam" IMRT
works by using 8-12 small radiation beams to give a more "tailored" or "customized" radiation
dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT
may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is
to reduce complications after irradiation to the implants.
The study doctors have recently completed a trial using this technique and are now
specifically looking at its impact on women with implant reconstructions who are undergoing
post-mastectomy radiation therapy. By delivering a more "customized" dose of radiation to the
implant, the intent is to reduce side effects of radiation on the implant.
Patients will undergo mastectomy and axillary dissection with immediate tissue expander
placement. As is the current practice at MSKCC, patients receiving adjuvant chemotherapy will
undergo expansion during chemotherapy, with exchange for a permanent implant to be performed
approximately one month after chemotherapy and radiation to begin approximately one month
after exchange. Patients who receive neoadjuvant chemotherapy will undergo "rapid expansion"
of the expander and begin radiation at least 4 weeks following surgery, although it may be
performed sooner if the patient has recovered from surgery and the treating physician deems
it safe to proceed with treatment. In these patients, exchange for the permanent implant will
occur at the discretion of the treating plastic surgeon (approximately 5-8 months after the
end of radiation).
placement. As is the current practice at MSKCC, patients receiving adjuvant chemotherapy will
undergo expansion during chemotherapy, with exchange for a permanent implant to be performed
approximately one month after chemotherapy and radiation to begin approximately one month
after exchange. Patients who receive neoadjuvant chemotherapy will undergo "rapid expansion"
of the expander and begin radiation at least 4 weeks following surgery, although it may be
performed sooner if the patient has recovered from surgery and the treating physician deems
it safe to proceed with treatment. In these patients, exchange for the permanent implant will
occur at the discretion of the treating plastic surgeon (approximately 5-8 months after the
end of radiation).
Inclusion Criteria:
- Females who are age ≥ 18 years of age with a life expectancy estimated to be at least
2 years
- Histologically-confirmed invasive breast cancer by MSKCC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Status post mastectomy with surgical assessment of axillary nodes
- Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1)
prior to RT performed at MSKCC
- If PMRT is recommended, the treatment fields will include the axillary,
supraclavicular, and internal mammary nodes.
Exclusion Criteria:
- Absence of a breast reconstruction prior to RT (placement of tissue expander is
sufficient for group 2)
- Pregnant or breastfeeding.
- Psychiatric or addictive disorders that would preclude obtaining informed consent or
filling out Breast-Q© questionnaires.
- Prior radiation therapy to the ipsilateral breast/nodes or thorax.
- The criterias outlined above apply to the patients enrolled to meet the primary
objective of the study. Additional criteria for patients in the cardiac substudy
portion of the protocol are outlined in the protocol
We found this trial at
7
sites
1000 N Village Ave
Rockville Centre, New York 11570
Rockville Centre, New York 11570
(516) 256-3600
Phone: 212-639-6773
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 212-639-6773
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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