- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04284215
Efficacy and Safety of Albumin Paclitaxel Combined With Cisplatin Chemoradiotherapy for Non-resectable Stage III NSCLC
Department of Oncology, Affiliated Hospital of Guizhou Medical University
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Guizhou
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Guiyang, Guizhou, 중국, 550001
- Affiliated Hospital of Guizhou Medical University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with NSCLC confirmed by pathology or cytology; clinical stage III [AJCC 8th Edition stage];
- Informed consent signed before treatment (radiotherapy, chemotherapy);
- no contraindication of radiotherapy and chemotherapy; .IMRT or VMAT technology is required to achieve the prescription dose of primary tumor (DTGTV): > 60Gy, normal lung in the design of radiotherapy plan.
- (Total Lung Volume minus GTV Volume) V20 < 32% were randomly enrolled in the study. [Planning Assessment: Prescription dose includes 100% GTV, 90% .prescription dose includes 98%~100% PTV] [Age 18-80 years old, body condition score ECOG0-2 or KPS (>70) ];
- [Subjects had no major organ dysfunction, blood routine, lung, liver and kidney. With normal function and cardiac function, laboratory tests must meet the following requirements: leukocyte (>4.0 *109/L), neutrophil (>2.0 *109/L), platelet (>100 *109/L) and hemoglobin (>100 g/L). Liver function: normal range. Renal function: normal range .Lung function: FEV1 > 50%, mild to moderate lung function impairment. _Patients have good compliance with the treatment and follow-up.
Exclusion Criteria:
- Pathological types, stages and survival status of patients who did not meet the criteria for enrollment
- Patients with uncontrollable hypertension, diabetes mellitus, unstable angina, history of myocardial infarction or symptomatic congestive heart failure or uncontrollable arrhythmia in the past 12 months; .Clinically diagnosed valvular disease; active period of bacterial, fungal or viral infections; mental disorders; and severe heart failure.
- Pulmonary impairment; Pregnancy and lactation patients;
- Patients with a history of active malignancies other than small cell lung cancer before admission;
- Patients with non-melanoma skin basal cell carcinoma, cervical cancer in situ, and cured early prostate cancer except; .Allergic constitution and known or suspected drug allergy in any study. .Patients without alternative drugs, patients with poor compliance, and researchers do not consider it appropriate to participate in this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Albumin paclitaxel
Albumin paclitaxel 40mg/m2/week was injected into normal saline at the same time as radiotherapy, once a week. Cisplatin 75 mg/m2 was given intravenously for 2-3 days , carboplatin 300 mg/m2 and 2 days. (Because toxicity and heart problems can replace DDP)] Repeat every cycle (21-28 days/cycle, minimum 2 cycles). Three-dimensional radiotherapy: intensity-modulated radiotherapy (IMRT) or rotational intensity-modulated radiation therapy (VMAT) segmented dose: primary focus and mediastinal metastatic lymph nodes; segmented mode: continuous accelerated hypersegmentation; Dose: DTGTV: > 60 Gy |
Non-resectable stage III non-small cell lung cancer is recommended for concurrent chemoradiotherapy.
Paclitaxel and platinum are commonly used in chemotherapy regimens.
The aim of this study was to investigate whether paclitaxel albumin combined with cisplatin combined with three-dimensional primary radiotherapy could improve short-term efficacy, local progression-free survival, and reduce treatment-related toxicity.
To determine whether paclitaxel albumin combined with cisplatin regimen chemotherapy can be used as a first-line treatment for stage III non-small cell lung cancer with concurrent primary thoracic radiotherapy.
다른 이름들:
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활성 비교기: Paclitaxel
Paclitaxel 175 mg/m2 was injected into saline solution on the first day. Cisplatin 75 mg/m2 was given intravenously for 2-3 days , carboplatin 300 mg/m2 and on the second day. (Because toxicity and heart problems can replace DDP)]Repeated every cycle (21-28 days/cycle, minimum 2 cycles). Three-dimensional radiotherapy: intensity-modulated radiotherapy (IMRT) or rotational intensity-modulated radiation therapy (VMAT) segmented dose: primary focus and mediastinal metastatic lymph nodes; segmented mode: continuous accelerated hypersegmentation; Dose: DTGTV: > 60 Gy |
Non-resectable stage III non-small cell lung cancer is recommended for concurrent chemoradiotherapy.
Paclitaxel and platinum are commonly used in chemotherapy regimens.
The aim of this study was to investigate whether paclitaxel albumin combined with cisplatin combined with three-dimensional primary radiotherapy could improve short-term efficacy, local progression-free survival, and reduce treatment-related toxicity.
To determine whether paclitaxel albumin combined with cisplatin regimen chemotherapy can be used as a first-line treatment for stage III non-small cell lung cancer with concurrent primary thoracic radiotherapy.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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ORR
기간: 2 years
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Efficacy of Concurrent chemoradiotherapy
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Side effection
기간: 2 years
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bone marrow suppression, hepatic and renal toxicity, cardiac toxicity, radiation pneumonia and other toxic and side effects caused by treatment
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Bing Lu, Bachelor, Affiliated Hospital of Guizhou Medical University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- GuizhouMu
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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