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임상시험 NCT06568705은(는) 유방암에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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베이징 셰허 의학원Hypofractionated Online Adaptive Radiotherapy of Breast Cancer 2상 40 적응형 설계
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06568705은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 유방암에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 9월 1일에 시작되어 40명의 참여자를 모집하고 있습니다. 베이징 셰허 의학원이(가) 진행하며, 2026년 12월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 20일에 갱신되었습니다.
간단한 개요
The goal of this clinical trial is to explore the application of online adaptive radiotherapy in patients who receive moderate hypofractionated or ultrafractionated radiotherapy after breast cancer surgery. The main questions it aims to answer are:
- Can online adaptive radiotherapy improve the accuracy of dose delivery?
- In patients undergoing online adaptive radiotherapy, how are the treatment-related toxicities ...
상세한 설명
Online Adaptive Radiotherapy (ART) is an evolution of image-guided radiotherapy that compresses the entire process of image acquisition, plan design, verification, and radiation delivery into approximately 10-30 minutes during which patients do not need to leave the treatment bed. Online ART features rapid image acquisition, automatic contouring and plan optimization supported by artificial intelligence. Body positio...더 보기
공식 제목
Hypofractionated Online Adaptive Radiotherapy of Breast Cancer
질환명
유방암기타 연구 식별자
- HF_BCoART
NCT 번호
실제 연구 시작일
2024-09-01
최신 업데이트 게시
2026-03-20
예상 연구 완료일
2026-12
계획된 등록 인원
40
연구종류
중재연구
단계/상
2상
상태
모집중
키워드
Online Adaptive Radiotherapy
Breast Cancer
Hypofractionated Radiotherapy
Breast Cancer
Hypofractionated Radiotherapy
주요 목적
치료
설계 할당
비랜덤화 배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적26Gy/5f online adaptive radiotherapy The CTV receives a dose of 26Gy in 5 fractions by online adaptive radiotherapy. | Ultrafractionated Radiation Treatment The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 26Gy in 5 fractions in patients who underwent breast conserving surgery or mastectomy. |
활성 대조군43.5Gy/15f online adaptive radiotherapy The CTV receives a dose of 43.5Gy in 15 fractions by online adaptive radiotherapy. | Moderate hypofractionated Radiation Treatment The online adaptive radiotherapy workflow is used to deliver radiation dose. The CTV of ipsilateral breast receives a dose of 43.5Gy in 15 fractions in patients who underwent breast conserving surgery or mastectomy. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The dose coverage of target volume as assessed by planning tumor volume V100% | Planning tumor volume V100%, defined as the planning tumor volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume. | 3 months after radiotherapy |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Treatment-related toxicity | Toxicity is evaluated by Common Terminology Criteria for Adverse Events v5.0. | Baseline; Every week during radiotherapy; 1 week, 2 weeks, 3/6/12/24 months after radiotherapy. |
Local recurrence rate (LRR) | LRR will be deducted from the local recurrence survival defined as the interval between date of surgery and the occurrence of local relapse. | 3, 6, 12, 24 months after radiotherapy |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
35 Years
참여 가능한 성별
여성
- Female, aged ≥35 years, <70 years
- ECOG score: 0-2
- Having underwent breast-conserving surgery or Modified radical mastectomy with or without sentinel lymph node biopsy or axillary lymph node dissection
- Pathologically confirmed primary breast cancer
- For patients who did not receive neoadjuvant therapy: pathological staged pT0-2N0-1; for patients who received neoadjuvant therapy: staged ypT0-2N0-1
- Indicated for postoperative adjuvant radiotherapy, planned to undergo postoperative adjuvant radiotherapy
- Able to cooperate and tolerate the treatment
- Pathologically confirmed metastasis in supraclavicular or infraclavicular lymph nodes, or distant metastasis
- History of radiotherapy to the neck or chest
- Contraindications or intolerance to radiation therapy (such as pregnancy or lactation, severe impairment of heart, lung, kidney, liver, or other vital organ functions; severe infection or hematologic abnormalities; brachial plexus nerve injury on the affected side; active connective tissue diseases, etc.)
- History of malignant tumors
베이징 셰허 의학원482개의 진행 중인 임상시험 탐색 가능연구 대표 연락처
연락처: Xiaorong Hou, MD, +86-13811963013, [email protected]
연락처: Xiaorong Hou, +86-13811963013, [email protected]
1 1개국에 임상시험 장소
Peking Union Medical College Hospital, Beijing, China
Xiaorong Hou, MD, 연락처, +86-13811963013, [email protected]
모집중