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
調査の概要
詳細な説明
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Junjie Wang, MD
- 電話番号：5920 010-82266699
- メール：junjiewang_edu@sina.com
研究場所
-
-
Beijing
-
Beijing、Beijing、中国、100191
- Peking University 3rd hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
observation group
All patients will be treated with Nimotuzumab combined with radiotherapy.
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
3-year disease-free survival(DFS)
時間枠：up to 3 years
|
The rate of patient without disease in 3 years after treatment
|
up to 3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Complete response rate(CRR)
時間枠：3 months later after treatment
|
The percentage of subjects who achieve complete response by imaging assessment from the end of the treatment to disease progression
|
3 months later after treatment
|
|
Objective response rate(ORR)
時間枠：3 months later treatment
|
The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment
|
3 months later treatment
|
|
3-year overall survival(OS)
時間枠：up to 3 years
|
The rate of patient alive in 3 years after treatment
|
up to 3 years
|
|
The change of tumor related markers
時間枠：up to 3 years
|
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]
|
up to 3 years
|
|
The change of cervical tumor
時間枠：At diagnosis and before brachytherapy
|
the change of the volume of the cervical tumor at diagnosis and before brachytherapy
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At diagnosis and before brachytherapy
|
|
QUALITY OF LIFE(QoL)
時間枠：up to 3 years
|
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]
|
up to 3 years
|
|
SAFETY
時間枠：up to 3 years
|
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
|
up to 3 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ChiECRCT20210238
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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