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Radiation Therapy in Treating Patients With Recurrent Breast Cancer

6 sierpnia 2020 zaktualizowane przez: Case Comprehensive Cancer Center

Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.

PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

OBJECTIVES:

  • To determine the in breast recurrence rate following repeat radiation to the breast. These patients will be followed for a period of five years following completion of radiation to determine these rates.
  • To determine the cosmetic outcome resulting from partial breast re-irradiation using different techniques, including both physician and patient rated scales.
  • To determine patient satisfaction of partial breast re-irradiation as it pertains to their overall treatment experience, as measured by a questionnaire.
  • To determine if there are patient factors illuminated during a discussion of informed consent, which limit a patient's suitability to receive partial breast re-irradiation delivered by a particular technique.
  • To evaluate tylectomy wound healing and overall complication rate after partial breast re-irradiation.
  • To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.These patients will be followed for a period of five years following completion of the second course of radiation to determine these rates.

OUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.

All patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity.

  • Group 1: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
  • Group 2: Patients undergo partial breast irradiation delivered by Mammosite® brachytherapy consisting of 10 fractions over 5 days.

Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.

After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

13

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Ohio
      • Cleveland, Ohio, Stany Zjednoczone, 44106-5065
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
      • Cleveland, Ohio, Stany Zjednoczone, 44122
        • UHHS Chagrin Highlands Medical Center
      • Cleveland, Ohio, Stany Zjednoczone, 44145
        • UHHS Westlake Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
  • Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)
  • Unifocal breast cancer recurrence
  • Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision
  • Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.
  • Signed study-specific informed consent prior to study entry.

Exclusion Criteria:

  • Patients with distant metastatic disease
  • Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.
  • Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
  • Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
  • Patients with Paget's disease of the nipple.
  • Patients with skin involvement.
  • Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
  • Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
  • Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study.
  • Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
  • Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intraoperative radiation therapy
Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Promieniowanie: intraoperative radiation therapy
Patients undergo radiotherapy
Eksperymentalny: Intracavitary balloon brachytherapy
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
Promieniowanie: intracavitary balloon brachytherapy
Patients undergo brachytherapy

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Ipsilateral Breast Tumor Recurrence Rates
Ramy czasowe: 1 month after radiation therapy (RT)
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
1 month after radiation therapy (RT)
Ipsilateral Breast Tumor Recurrence Rates
Ramy czasowe: 3 months after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
3 months after RT
Ipsilateral Breast Tumor Recurrence Rates
Ramy czasowe: 6 months after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
6 months after RT
Ipsilateral Breast Tumor Recurrence Rates
Ramy czasowe: 9 months after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
9 months after RT
Ipsilateral Breast Tumor Recurrence Rates
Ramy czasowe: 12 months after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
12 months after RT
Ipsilateral Breast Tumor Recurrence Rates
Ramy czasowe: 2 years after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
2 years after RT
Ipsilateral Breast Tumor Recurrence Rates
Ramy czasowe: 3 years after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
3 years after RT
Ipsilateral Breast Tumor Recurrence Rates
Ramy czasowe: 4 years after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
4 years after RT
Ipsilateral Breast Tumor Recurrence Rates
Ramy czasowe: 5 years after RT
Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.
5 years after RT
Tumor Bed Recurrence Rates
Ramy czasowe: 1 month after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
1 month after RT
Tumor Bed Recurrence Rates
Ramy czasowe: 3 month after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
3 month after RT
Tumor Bed Recurrence Rates
Ramy czasowe: 6 month after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
6 month after RT
Tumor Bed Recurrence Rates
Ramy czasowe: 12 month after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
12 month after RT
Tumor Bed Recurrence Rates
Ramy czasowe: 2 years after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
2 years after RT
Tumor Bed Recurrence Rates
Ramy czasowe: 3 years after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
3 years after RT
Tumor Bed Recurrence Rates
Ramy czasowe: 4 years after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
4 years after RT
Tumor Bed Recurrence Rates
Ramy czasowe: 5 years after RT
Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
5 years after RT
Cosmetic Outcome as Determined by an Established Scale
Ramy czasowe: 1 month after RT & Q3mos for one year and at 5 years

Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, with levels poor, fair, good, and excellent in increasingly positive outcomes.

Excellent: Minimal or no difference in the size or shape of the treated breast Good: Slight difference in the size or shape of the treated breast Fair: Obvious difference in the shape and size of the treated breast Poor: Obvious difference in the shape and size of the treated breast
1 month after RT & Q3mos for one year and at 5 years
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Ramy czasowe: 1 month after RT

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

  1. I am totally satisfied with the treatment and results
  2. I am not totally satisfied but would choose the same treatment again.
  3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
  4. I am dissatisfied with my treatment.
1 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Ramy czasowe: 3 month after RT

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

  1. I am totally satisfied with the treatment and results
  2. I am not totally satisfied but would choose the same treatment again.
  3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
  4. I am dissatisfied with my treatment.
3 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Ramy czasowe: 6 month after RT

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

  1. I am totally satisfied with the treatment and results
  2. I am not totally satisfied but would choose the same treatment again.
  3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
  4. I am dissatisfied with my treatment.
6 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Ramy czasowe: 9 month after RT

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

  1. I am totally satisfied with the treatment and results
  2. I am not totally satisfied but would choose the same treatment again.
  3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
  4. I am dissatisfied with my treatment.
9 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Ramy czasowe: 12 month after RT

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

  1. I am totally satisfied with the treatment and results
  2. I am not totally satisfied but would choose the same treatment again.
  3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
  4. I am dissatisfied with my treatment.
12 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Ramy czasowe: 2 years after RT

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

  1. I am totally satisfied with the treatment and results
  2. I am not totally satisfied but would choose the same treatment again.
  3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
  4. I am dissatisfied with my treatment.
2 years after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Ramy czasowe: 3 years after RT

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

  1. I am totally satisfied with the treatment and results
  2. I am not totally satisfied but would choose the same treatment again.
  3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
  4. I am dissatisfied with my treatment.
3 years after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Ramy czasowe: 4 years after RT

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

  1. I am totally satisfied with the treatment and results
  2. I am not totally satisfied but would choose the same treatment again.
  3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
  4. I am dissatisfied with my treatment.
4 years after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey
Ramy czasowe: 5 years after RT

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

  1. I am totally satisfied with the treatment and results
  2. I am not totally satisfied but would choose the same treatment again.
  3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
  4. I am dissatisfied with my treatment.
5 years after RT
Percent of Participants Experiencing Complications After Intervention
Ramy czasowe: 1 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
1 month after RT
Percent of Participants Experiencing Complications After Intervention
Ramy czasowe: 3 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
3 month after RT
Percent of Participants Experiencing Complications After Intervention
Ramy czasowe: 6 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
6 month after RT
Percent of Participants Experiencing Complications After Intervention
Ramy czasowe: 9 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
9 month after RT
Percent of Participants Experiencing Complications After Intervention
Ramy czasowe: 12 month after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
12 month after RT
Percent of Participants Experiencing Complications After Intervention
Ramy czasowe: 2 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
2 years after RT
Percent of Participants Experiencing Complications After Intervention
Ramy czasowe: 3 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
3 years after RT
Percent of Participants Experiencing Complications After Intervention
Ramy czasowe: 4 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
4 years after RT
Percent of Participants Experiencing Complications After Intervention
Ramy czasowe: 5 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
5 years after RT

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percent of Participants With Delayed Wound Healing
Ramy czasowe: 1 month after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
1 month after RT
Percent of Participants With Delayed Wound Healing
Ramy czasowe: 3 month after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
3 month after RT
Percent of Participants With Delayed Wound Healing
Ramy czasowe: 6 month after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
6 month after RT
Percent of Participants With Delayed Wound Healing
Ramy czasowe: 9 month after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
9 month after RT
Percent of Participants With Delayed Wound Healing
Ramy czasowe: 12 month after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
12 month after RT
Percent of Participants With Delayed Wound Healing
Ramy czasowe: 2 years after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
2 years after RT
Percent of Participants With Delayed Wound Healing
Ramy czasowe: 3 years after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
3 years after RT
Percent of Participants With Delayed Wound Healing
Ramy czasowe: 4 years after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
4 years after RT
Percent of Participants With Delayed Wound Healing
Ramy czasowe: 5 years after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
5 years after RT

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Case Comprehensive Cancer Center

Śledczy

  • Główny śledczy: Janice Lyons, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

23 września 2008

Zakończenie podstawowe (Rzeczywisty)

6 lipca 2018

Ukończenie studiów (Rzeczywisty)

6 lipca 2018

Daty rejestracji na studia

Pierwszy przesłany

22 lipca 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 lipca 2009

Pierwszy wysłany (Oszacować)

23 lipca 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 sierpnia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 sierpnia 2020

Ostatnia weryfikacja

1 sierpnia 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CASE11107

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Rak piersi

Badania kliniczne na intraoperative radiation therapy

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Sponsorzy i współpracownicy

Warunki medyczne

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CROs by country

CROs in Venezuela

Warunki

Rzadkie choroby

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Sponsor / Współpracownicy

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