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Conventional Versus Hypofractionated Radiotherapy in Node Positive Breast Cancer

2016년 5월 29일 업데이트: Mahmoud Ellithy, Ain Shams University

Conventional Versus Hypofractionated Adjuvant Radiotherapy in Node Positive Breast Cancer. Phase III, Open Label, Randomized Trial. Comparing Local Control, Cosmetic Outcome, Arm Lymph Edema and Health Economic Perspectives

Breast cancer patients operated with modified radical mastectomy or breast conservative surgery will be randomized for either adjuvant conventional radiotherapy versus hypofractionated radiotherapy for chest wall and axilla or breast and axilla.

The patients will be recruited for one year and will be followed for 5 years by monitoring local recurrence, cosmetic outcomes, health economic perspectives, and arm lymph edema.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

상세 설명

The investigators hypothesize that hypofractionated radiotherapy in node positive breast cancer is equally effective and safe as conventional fractionated radiotherapy. Breast cancer patients with pathological positive lymph nodes (N1 - N2) operated with modified radical mastectomy will be randomized 1:1 and also those with breast conservative surgery with positive lymph nodes will be randomized 1:1 for receiving either adjuvant conventional radiotherapy 200cgy x 25 fractions with 200cgy x 5 fractions boost for those with intact breast versus hypofractionated radiotherapy 266cgyx16 fractions and 266 cgy x 4 fractions boost for those with intact breast. The patients will be followed for 5 years to monitor locoregional recurrence, cosmetic outcomes, ipsilateral arm lymph edema. Health economic perspectives will be monitored by calculating cost effective analysis for both treatment plans.

연구 유형

중재적

등록 (예상)

500

단계

  • 3단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 이집트
    • Abbasia
      • Cairo, Abbasia, 이집트, 14031
        • 모병
        • Mahmoud Ellithy
        • 연락하다:
        • 부수사관:
          • Heba Abdallah, Specialist
        • 부수사관:
          • Ahmed Nagy, Consultant
        • 부수사관:
          • Lamia Elwakil, Pharmacist
        • 부수사관:
          • Noha Elboghdady, Pharmacist
        • 부수사관:
          • Ahmad Abdel-Hady, Consultant
        • 부수사관:
          • Wael Elsheshtawy, Consultant
        • 부수사관:
          • Rasha Haggag, Consultat
        • 부수사관:
          • Mohamed A. Alm El-Din, Consultant
        • 부수사관:
          • Mostafa Elnaggar, Consultant
        • 부수사관:
          • Marwa I. Abdelgawad, Consultant
        • 부수사관:
          • Abdelmoneim Elsayed, Consultant

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

20년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  1. ECOG. (Eastern Cooperative Oncology Group): 0-2
  2. Histologic documentation of invasive duct or lobular adenocarcinoma of the breast
  3. If neoadjuvant chemotherapy was NOT administered: pathologic T1-3, N1-2 following definitive surgery

  4. If neoadjuvant chemotherapy was administered, pathology from the definitive surgery must confirm pathologic T1-3, N1-2 disease and also meet one of the following criteria:

    Clinical T1-3, N1-2 or Pathologic confirmation of axillary nodal involvement at presentation (ie, before neoadjuvant therapy) based on any of the following: Positive fine-needle aspiration (FNA), Positive core needle biopsy.

  5. Complete resection of known breast disease by one of the following surgeries Lumpectomy with axillary lymph node dissection with no more than 12 resected lymph nodes.

Mastectomy and axillary lymph node dissection with no more than 12 resected lymph nodes.

5- ER(estrogen-receptor), PR (progesterone-receptor), and HER2(human epidermal growth factor receptor 2) testing performed on the primary breast tumor; when applicable, testing must have been performed before receiving neoadjuvant chemotherapy.

6-Margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the pathologist.

7-The surgical wound should be completely healed without any signs of infection.

8-Interval between the last surgery for breast cancer or the completion of adjuvant chemotherapy and study enrollment must be ≤ 56 days (ie, a maximum of 8 weeks).

9-If adjuvant chemotherapy is received there should be at least 10 days gap between the last day of chemotherapy and the enrollment in the study to avoid skin toxicity.

10-Women of child-bearing potential must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment 11-Ability to understand and willingness to sign the consent form written in Arabic

Exclusion Criteria:

  1. Patients with surgical margins less than or equal to 2mm.
  2. Patients with axillary dissection of more than 12 lymph nodes due to high incidence of arm lymphedema.
  3. Women with Huge pendulous breast.
  4. Patients with bad breast conservative surgery ( Surgery that impair the cosmetic outcome before starting radiotherapy).
  5. T4 tumors including inflammatory breast cancer.
  6. Known definitive clinical or radiologic evidence of metastatic disease.
  7. Patients re operated for microscopic positive margins after definitive surgery.
  8. Previous radiation therapy for the currently diagnosed breast cancer prior to study enrollment
  9. History of ipsilateral or contralateral breast or thoracic radiotherapy for any condition
  10. History of ipsilateral or contralateral axillary surgery for any condition
  11. History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past
  12. Active collagen vascular disease, specifically dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  13. Pregnancy or breastfeeding
  14. Second primary cancer.

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Conventional
The patients will receive adjuvant radiotherapy conventionally fractionated 5000 cgy fractionated by 200cgy daily fractions, five fractions per week over 5 weeks with an additional 200cgy daily for five days as boost for patients with breast conservative surgery.
방사능: radiotherapy
daily fractions, five fractions per week.
실험적: Hypofractionated
The patients will receive adjuvant radiotherapy hypofractionated 266cgy daily fractions, five fractions per week for total 16 fractions and an additional five daily fractions will be added as boost for patients with breast conservative surgery.
방사능: radiotherapy
daily fractions, five fractions per week.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Locoregional recurrence
기간: 5 years

Tumor locoregional recurrence is defined as: Any newly suspicious skin change/s or palpable lymph node in the irradiated area (compared to baseline photo and clinical examination of this area) that is/are pathologically proved to be locoregional tumor recurrence.

Suspicious skin change/s and palpable lymph node from baseline photo and baseline clinical examination of the irradiated area will be monitored at 3 months throughout 5 years following the completion of radiotherapy in the two study arms to detect the incidence and time of locoregional recurrence.
5 years
Cosmetic outcomes
기간: 5 years

Aesthetic evaluation of the irradiated breast will be through 3 methods. Patient questionnaire (Subjective evaluation), Harvard score for breast cosmoses (Observer evaluation) and a computer soft ware that calculate the configuration difference between treated and non treated breast. Upon evaluation, each of the three methods will acquire a point ranging from 0 to 3 (poor to excellent cosmetic outcome respectively). The points of the three methods will be added yielding a score ranging from 0 to 9. Score 0-2, 3-4, 5-6 and 7-9 mean poor, fair, good and excellent cosmoses respectively.

The cumulative incidence of changes in breast cosmoses from baseline for every patient will be assessed every year (as described above) through out the 5 years (Time frame of the study) following the completion of radiotherapy in the two study arms. By the end of the five years the aesthetic evaluation for each patient will be through calculating the average of her 5 years score.
5 years
Arm lymph edema.
기간: 5 years
To evaluate the cumulative incidence of lymph edema during the 5 years following completion of hypofractionated radiation treatment [ Time Frame: 5 years ] Incidence of lymphedema defined as ≥ 10% increase in arm circumference over baseline circumference compared to the contralateral arm measured every 6 months from the time of initiation of hypofractionated irradiation of breast and regional nodes through 5 years following the completion of radiation therapy in 2 study groups.
5 years
Health economic perspectives
기간: 5 years

The economic perspectives for the public health: (Time frame 5 years). Cost effective analysis of each treatment plan will be evaluated at the end of 5 years through calculation of the cost-effectiveness ratio = Cost of intervention / Health effect produced.

The cost of intervention = the sum of (Cost of medical staff time, drugs and equipment maintenance during the 5 years time frame). (The cost of intervention during the 5 years time frame will be used for calculations).

The health effect produced will be years of local control (Number of years the patient lived without any pathological evidence of local recurrence). (The mean years of local control during the 5 years time frame will be used for calculations).

The treatment program with the less cost effectiveness ratio will be recommended for treating patients.
5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ain Shams University

협력자

Zagazig University
Cairo University
Assiut University
Al-Azhar University
Mit Ghamr Oncology Center
Clinical Oncology department. Elmansoura University.
Clinical Oncology department. Tanta University.
Medical Research Institute. Department of Cancer Management and Research.
Clinical Oncology Department. Banha University.
Ayadi El Mostakbal Cancer Center. Alexandria.

수사관

  • 수석 연구원: Mahmoud Ellithy, Phd, ain shams University

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

2016년 1월 1일

기본 완료 (예상)

2021년 2월 1일

연구 완료 (예상)

2021년 4월 1일

연구 등록 날짜

최초 제출

2016년 1월 29일

QC 기준을 충족하는 최초 제출

2016년 2월 23일

처음 게시됨 (추정)

2016년 2월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 5월 29일

마지막으로 확인됨

2016년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Cure and More3

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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

radiotherapy에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Kuwait

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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