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Radiation Therapy in Treating Patients With Recurrent Breast Cancer

6. srpna 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

13

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intraoperative radiation therapy
Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Záření: intraoperative radiation therapy
Patients undergo radiotherapy
Experimentální: Intracavitary balloon brachytherapy
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
Záření: intracavitary balloon brachytherapy
Patients undergo brachytherapy

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Ipsilateral Breast Tumor Recurrence Rates
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 5 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
5 years after RT

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percent of Participants With Delayed Wound Healing
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 5 years after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
5 years after RT

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Case Comprehensive Cancer Center

Vyšetřovatelé

  • Vrchní vyšetřovatel: Janice Lyons, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

23. září 2008

Primární dokončení (Aktuální)

6. července 2018

Dokončení studie (Aktuální)

6. července 2018

Termíny zápisu do studia

První předloženo

22. července 2009

První předloženo, které splnilo kritéria kontroly kvality

22. července 2009

První zveřejněno (Odhad)

23. července 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. srpna 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. srpna 2020

Naposledy ověřeno

1. srpna 2020

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CASE11107

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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