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Radiation Therapy in Treating Patients With Recurrent Breast Cancer

6 agosto 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

13

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intraoperative radiation therapy
Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Radiazione: intraoperative radiation therapy
Patients undergo radiotherapy
Sperimentale: Intracavitary balloon brachytherapy
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
Radiazione: intracavitary balloon brachytherapy
Patients undergo brachytherapy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ipsilateral Breast Tumor Recurrence Rates
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 5 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
5 years after RT

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent of Participants With Delayed Wound Healing
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 5 years after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
5 years after RT

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Case Comprehensive Cancer Center

Investigatori

  • Investigatore principale: Janice Lyons, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 settembre 2008

Completamento primario (Effettivo)

6 luglio 2018

Completamento dello studio (Effettivo)

6 luglio 2018

Date di iscrizione allo studio

Primo inviato

22 luglio 2009

Primo inviato che soddisfa i criteri di controllo qualità

22 luglio 2009

Primo Inserito (Stima)

23 luglio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 agosto 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2020

Ultimo verificato

1 agosto 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CASE11107

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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