Radiation Therapy in Treating Patients With Recurrent Breast Cancer
6. august 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
13
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44106-5065
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
-
Cleveland, Ohio, Forenede Stater, 44122
- UHHS Chagrin Highlands Medical Center
-
Cleveland, Ohio, Forenede Stater, 44145
- UHHS Westlake Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intraoperative radiation therapy
Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
|
Patients undergo radiotherapy
|
|
Eksperimentel: Intracavitary balloon brachytherapy
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
|
Patients undergo brachytherapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ipsilateral Breast Tumor Recurrence Rates
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 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
Tidsramme: 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"
|
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
Tidsramme: 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"
|
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
Tidsramme: 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"
|
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
Tidsramme: 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"
|
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
Tidsramme: 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"
|
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
Tidsramme: 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"
|
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
Tidsramme: 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"
|
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
Tidsramme: 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"
|
5 years after RT
|
|
Percent of Participants Experiencing Complications After Intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 5 years after RT
|
Overall complication rate, as measured by percent of participants experiencing complications after intervention
|
5 years after RT
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent of Participants With Delayed Wound Healing
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 5 years after RT
|
Wound healing rate, as measured by percent of participants with delayed wound healing
|
5 years after RT
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Janice Lyons, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. september 2008
Primær færdiggørelse (Faktiske)
6. juli 2018
Studieafslutning (Faktiske)
6. juli 2018
Datoer for studieregistrering
Først indsendt
22. juli 2009
Først indsendt, der opfyldte QC-kriterier
22. juli 2009
Først opslået (Skøn)
23. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. august 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. august 2020
Sidst verificeret
1. august 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CASE11107
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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