Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
연구 개요
상세 설명
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Junjie Wang, MD
- 전화번호: 5920 010-82266699
- 이메일: junjiewang_edu@sina.com
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100191
- Peking University 3rd hospital
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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:
- Age≥65 years old
- Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)
- At least one measurable lesion according to RECIST 1.1 guideline
- Patients are intolerant to or refuse chemotherapy.
No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:
Hemoglobin ≥90g/L Absolute count of neutrophils≥2×109/L orwhite blood cell count≥4.0×109/L； Platelet count≥100×109/L； AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN；
Serum creatinine≤1.5×ULN or CrCl> 60 mL/min(according toCockcroft-Gault):
Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight（kg）×0.85 / (72×Scr mg/dl)
- ECOG score 0-2
- Expectancy of life is at least 3 months.
- Eligible for pelvic MRI examination.
- The patients voluntarily received nimotuzumab combined with radiotherapy.
- Patients can comply with the protocol and are willing to sign informed consent.
Exclusion Criteria:
- Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy
- Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.
- Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or with fistula risk.
.4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.
7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.
8)Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability.
11)Intracavitary brachytherapy cannot be performed that was assessed by the investigator.
12)Other factors were assessed by investigators to be unsuitable to this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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observation group
All patients will be treated with Nimotuzumab combined with radiotherapy.
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Patients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks.
IMRT/VMAT are adopted. A total dose of 45-50.4 Gy, 1.8~2.0Gy/f, 25~ 28F in pelvic and/or extension filed. For patients with metastasis in pelvic lymph node and abdominal para-aortic lymph node, the dose of radiation in local lesion will be increased to 60~66Gy. For patients at stage IIIB, concurrent radiation will be given in parametrial extension or in the late course the dose will be increased to 60Gy. Brachytherapy: Three dimensional high dose rate brachytherapy is used with HR-CTV D90 cumulative dose of 80~85Gy (EQD2); If the tumor diameter is ≥4cm, HR-CTV D90 cumulative dose is ≥87Gy (EQD2). Brachytherapy combined with external beam radiotherapy will be completed within 8 weeks. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-year disease-free survival(DFS)
기간: up to 3 years
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The rate of patient without disease in 3 years after treatment
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up to 3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Complete response rate(CRR)
기간: 3 months later after treatment
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The percentage of subjects who achieve complete response by imaging assessment from the end of the treatment to disease progression
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3 months later after treatment
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Objective response rate(ORR)
기간: 3 months later treatment
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The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment
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3 months later treatment
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3-year overall survival(OS)
기간: up to 3 years
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The rate of patient alive in 3 years after treatment
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up to 3 years
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The change of tumor related markers
기간: up to 3 years
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the correlation of the value of SCC，Cyfra 21-1 and therapeutic effect [The changes of serum tumor markers (such as SCC-Ag and CYFRA21-1) were observed before and after treatment]
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up to 3 years
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The change of cervical tumor
기간: At diagnosis and before brachytherapy
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the change of the volume of the cervical tumor at diagnosis and before brachytherapy
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At diagnosis and before brachytherapy
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QUALITY OF LIFE(QoL)
기간: up to 3 years
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Quality of life assessed by EORTC QLQ-CX 24 [EORTC QLQ-CX 24 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 24 items]
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up to 3 years
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SAFETY
기간: up to 3 years
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Including severity of adverse events, the incidence of adverse events and serious adverse events.
Adverse events should be reported and graded according to CTCAE version 5.0
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up to 3 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
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
- ChiECRCT20210238
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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