- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01290809
Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) Patients
Cognitive Sequelae of Prophylactic Cranial Irradiation in Non-small Cell Lung Cancer Patients
Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of the lung cancer population. The prognosis of these patients has improved over the years due the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The brain, however, remains one of the major sites of failure. Patients with brain metastasis suffer from a variety of neurological, cognitive and emotional difficulties that are known to adversely affect the health-related quality of life. Prophylactic Cranial Irradiation (PCI) can prevent or delay the development of brain metastasis, and as such can improve neurological disease-free survival and consequently health-related quality of life. But survival is short, and toxicities are real, as PCI in itself can also induce adverse effects. The cognitive adverse effects of PCI are not sufficiently illuminated and documented, due to the lack of formal and systematic evaluation in patient populations expected to have short survival. Also, recent attempts to reduce cognitive side effects of PCI by the application of hippocampal-avoidance PCI in order to prevent memory deficits have not been fully evaluated yet.
Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs and benefits of this therapy should be investigated properly, to allow for well-informed treatment choices.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드
- VU University Medical Center
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Amsterdam, 네덜란드
- Academic Medical Center
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Amsterdam, 네덜란드
- NKI
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Groningen, 네덜란드
- University Medical Center Groningen
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- UICC stage III A or III B (without malignant pleural or pericardial effusion) non-small cell lung cancer
- Whole body PDG-PET scan before the start of therapy available: no distant metastasis.
- CT or preferably MRI of the brain before the start of radical therapy available; no brain metastasis.
- Platinum-based chemotherapy is mandatory.
- Radical local therapy: concurrent or sequential chemotherapy and radiotherapy with or without surgery.
- Radiotherapy dose without surgery to at least biological equivalent of 60 Gy.
- No prior cranial irradiation.sufficient proficiency in Dutch language
- sufficient proficiency in Dutch language
- MRI (and not CT scan) pre-PCI
Exclusion Criteria:
- none
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 크로스오버
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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Prophylactic Cranial Irradiation
NSCLC patients treated with whole brain PCI: cognitive functioning as assessed by neuropsychological tests?
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no Prophylactic Cranial Irradiation
NSCLC patients not treated with whole brain PCI: cognitive functioning as assessed by neuropsychological tests?
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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cognitive sequelae
기간: 36 months
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The proposed study will investigate the cognitive sequelae of PCI in NSCLC patients in the context of a phase III randomized trial (Nederlandse vereniging van artsen voor longziekten en tuberculose: NVALT-11) on the efficacy of PCI in decreasing the proportion of NSCLC patients developing brain metastasis, and the impact of PCI on neurological symptoms and health-related quality of life.
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36 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Dirk deruysscher, Maastro Clinic, The Netherlands
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd완전한
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