Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer
Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer: A Prospective, Single Arm, Phase II Clinical Trial
研究概览
详细说明
Because of the apparent heterogeneity of stage IVB cervical cancer, at present there is no standard treatment.
This is a Phase II, single-center, single-arm, study of systemic chemotherapy plus lesion radiotherapy for primary stage IVB cervical cancer.
The primary objective of the study is to test the hypothesis that primary lesion radiotherapy leads to an improvement in progression-free survival time (PFS)for stage IVB cervical cancer.
For those patients under the clinical management of the recruiting investigator, the investigator will review the patient's medical records and determine if they would be a candidate for the study.
Upon confirmation of all eligibility criteria, the subject will be enrolled.Patients with beyond abdominal pelvic lymph node metastasis will first undergo 2 cycle systemic chemotherapy(TP/TC),then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective(CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy),concurrent chemotherapy (TP/TC) may be given according to the patients tolerant,finally, the patient will complete a total of 6 cycles of chemotherapy(TP/TC).Distant metastasis of lymph node areas (e.g., supraclavicular, axillary, mediastinum, etc.) will be radiation after radiotherapy at the primary site according to patients tolerant.Patients with stage IVB cervical cancer with hematogenous metastasiswill first undergo 4 cycle systemic chemotherapy(TP/TC),then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective(CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy),concurrent chemotherapy (TP/TC) may be given according to the patients tolerant,finally, the patient will complete a total of 6 cycles of chemotherapy(TP/TC),after the primary radiotherapy, the treatment regimen for distant metastasis will be determined by MDT discuss or consultation.Quality of life will be evaluated before and after treatment. During therapy, the patient will have a weekly physical exam, vital signs collected, evaluation for pain, and review any side effects.
Subjects will undergo a post treatment follow-up period after completion of their radiation therapy. During this follow-up period, subjects will return for a medical and history review with a complete physical examination, review of any side effects, evaluation for outcomes and toxicity, and QoL.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310022
- 招聘中
- Zhejiang Cancer Hospital
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接触:
- ZhuoMin Yin
- 电话号码:0086-571-88122032
- 邮箱:yinzm@zjcc.org.cn
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接触:
- HanMei Lou, M.A.
- 电话号码:0086-571-88122038
- 邮箱:louhanmei@zjcc.org.cn
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma )
- KPS≥70
- FIGO stage IVB
- Age: 18-70
- ECOG (Eastern Cooperative Oncology Group) : 0-2
- The expected survival time is >6 months
- Chemotherapy and radiation have not been done before
- Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function)
- Able to understand this study and have signed informed consent.
Exclusion Criteria:
- Prior hysterectomy
- Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm
- Patients with brain metastasis or disseminated peritoneal metastasis
- Female in pregnancy or lactating
- Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy)
- History of major psychiatric disorder
- Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct
- Patient with any other disease or condition is a contraindication for chemoradiotherapy
- The researchers consider the patient not appropriate to be enrolled
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Chemotherapy,radiotherapy
Lymphatic metastasis patients undergoing 2 cycles of chemotherapy(TP/TC), blood metastasis patients receiving 4 cycles of chemotherapy, then patients with therapeutic evaluation for (CR+PR+SD) will undergo the radiotherapy (external irradiation plus brachytherapy) for primary lesion area , all patients completed total 6 cycles of chemotherapy (TP/TC), and finally will determine the of treatment plans of metastasis areas based on tolerance and discuss results by MDT.
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Pelvic,pelvic-inguinal,or extended field radiotherapy:Therapy 45 - 50 Gy in 1.7 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks for PTV Brachytherapy: Therapy 5-6 fractions of 4-6Gy prescribed to the high-risk CTV or A piont.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression-free survival time, PFS
大体时间:2 years
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Progression-free survival will be evaluated
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Patients with Adverse Events as a Measure of Safety
大体时间:2 years
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To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity
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2 years
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Objective Response Rates, ORR
大体时间:2 years
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Objective Response Rates will be evaluated
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2 years
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Overall survival
大体时间:2 years
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Overall survival will be evaluated
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2 years
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Ranking Quality of Life of Patients
大体时间:2 years
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To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and cervical cancer module(CX24).
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2 years
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Screening for potentially curable primary stage IVB cervical cancer
大体时间:2 years
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By follow-up data,screening for potentially curable primary stage IVB cervical cancer
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2 years
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合作者和调查者
调查人员
- 首席研究员:HanMei Lou, M.A.、Zhejiang Cancer Hospital
- 首席研究员:ZhuoMin Yin、Zhejiang Cancer Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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