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Radiation Therapy in Treating Patients With Recurrent Breast Cancer

6 août 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

13

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intraoperative radiation therapy
Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Radiation: intraoperative radiation therapy
Patients undergo radiotherapy
Expérimental: Intracavitary balloon brachytherapy
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
Radiation: intracavitary balloon brachytherapy
Patients undergo brachytherapy

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Ipsilateral Breast Tumor Recurrence Rates
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 5 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
5 years after RT

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percent of Participants With Delayed Wound Healing
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 5 years after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
5 years after RT

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Case Comprehensive Cancer Center

Les enquêteurs

  • Chercheur principal: Janice Lyons, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

23 septembre 2008

Achèvement primaire (Réel)

6 juillet 2018

Achèvement de l'étude (Réel)

6 juillet 2018

Dates d'inscription aux études

Première soumission

22 juillet 2009

Première soumission répondant aux critères de contrôle qualité

22 juillet 2009

Première publication (Estimation)

23 juillet 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 août 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 août 2020

Dernière vérification

1 août 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CASE11107

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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