External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks
A Phase I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer
Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the "tumor bed").
The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients.
The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
After signing the consent form, the following will be assessed.
-CT scan of the breast that had the cancer removed to help plan the radiation therapy. This is referred to as a CT-simulation. This scan is done routinely as part of the regular treatment.
PBI Study Treatment: You will be given PBI once daily over 10 treatment days (Mon-Fri) over a 2 week period. During this time you will have a weekly interview, physical examination, and your skin will be assessed for any side effects of the radiation.
PBI will begin between 4 weeks to 3 months after breast surgery or 2-6 weeks after chemotherapy (if you have been given chemotherapy).
After the final dose of the study:
You will have the following scheduled follow-up visits: one at the completion of the radiation, once or twice during weeks 3-9 after the completion of radiation, once every 6 months for five years, and then once every year for the following five years after the completion of radiation therapy.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Stany Zjednoczone, 02215
- Massachusetts General Hospital
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Boston, Massachusetts, Stany Zjednoczone, 02215
- Beth Isreal Deaconness Medical Center
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Boston, Massachusetts, Stany Zjednoczone, 02215
- Brigham and Women's Hosptial
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography
- Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen
- Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery
Exclusion Criteria:
- No distant metastasis
- Not pregnant or breastfeeding
- No diffuse suspicious microcalcifications
- No prior radiation therapy to the ipsilateral or contralateral breast or thorax
- No histologic evidence of lymphovascular invasion (LVI)
- No histologic evidence of EIC
- No history of cosmetic or reconstructive breast surgery
- No psychiatric illness that would prevent the patient from giving informed consent
- No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
- No other currently active second malignancy other than non-melanoma skin cancers
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Partial Breast Irradiation
Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks
|
40 Gy in ten daily fractions over two weeks
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks
Ramy czasowe: 2 years
|
The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.
The data is shown as the number of participants that experienced each of the specific toxicities. |
2 years
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Local Control Rates
Ramy czasowe: 2 years
|
The local control rates (analyzed separately for patients with DCIS and invasive cancer).
Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes.
Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one.
DCIS stands for 'Ductal Carcinoma In Situ'.
|
2 years
|
|
Distant Control Rates
Ramy czasowe: 2 years
|
The number of participants that achieved distant control.
Distant control is defined as a lack of distant metastasis following the completion of treatment.
Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain.
|
2 years
|
|
Breast Cosmesis
Ramy czasowe: End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years
|
Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria.
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End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 11-351
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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