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Radiation Therapy in Treating Patients With Recurrent Breast Cancer

2020년 8월 6일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

13

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intraoperative radiation therapy
Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
방사능: intraoperative radiation therapy
Patients undergo radiotherapy
실험적: Intracavitary balloon brachytherapy
Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.
방사능: intracavitary balloon brachytherapy
Patients undergo brachytherapy

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Ipsilateral Breast Tumor Recurrence Rates
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 5 years after RT
Overall complication rate, as measured by percent of participants experiencing complications after intervention
5 years after RT

2차 결과 측정

결과 측정
측정값 설명
기간
Percent of Participants With Delayed Wound Healing
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 5 years after RT
Wound healing rate, as measured by percent of participants with delayed wound healing
5 years after RT

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Case Comprehensive Cancer Center

수사관

  • 수석 연구원: Janice Lyons, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2008년 9월 23일

기본 완료 (실제)

2018년 7월 6일

연구 완료 (실제)

2018년 7월 6일

연구 등록 날짜

최초 제출

2009년 7월 22일

QC 기준을 충족하는 최초 제출

2009년 7월 22일

처음 게시됨 (추정)

2009년 7월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 8월 6일

마지막으로 확인됨

2020년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CASE11107

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

유방암에 대한 임상 시험

intraoperative radiation therapy에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Luxembourg

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다