IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer
IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer: Results of a Randomised,Openlabel,Multicentre Study
This study is for patients with EFGR gene sensitive mutations diagnosed by pathology or cytology, having a course of chest radiotherapy treatment and molecular Target Therapy for the treatment of stage IV non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.
In this study, the investigators aim to verify the following hypothesis:
- whether in combination with concurrent or concomitant EGFR-TKI regimen chemotherapy, Intensity Modulated Radiation Therapy can reduce the risk of the tumour in the lung recurring or progressing similarily.
- Intensity Modulated Radiation Therapy concomitant with EGFR-TKI has a better normal tissue dose/volume tolerance than concurrent regimen.
- the survival can be improved by using this new molecular Target-radiotherapy method.
研究概览
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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Guizhou
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Guiyang、Guizhou、中国、550004
- The Affiliated Hospital of Guizhou Medical University
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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:
- Histologically or cytologically confirmed stage IV NSCLC[UICC 2017 8th edition] with known sensitive EGFR mutations(confirmed by tissue or blood).
- Have not received one or more prior treatments
- 18 to 80 years of age.ECOG performance status 0~2 or KPS≥60
- Have distant metastatic lesions≤5;and have clear consciousness when the metastatic sites were brain; and have no influence on pulmonary function when the metastatic sites were lung.
- Have no contraindications in radiotherapy, EGFR-TKI and chemotherapy
- Normal bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1,500/mcl Platelets ≥ 100,000/mcl Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 2.0 x IULN AST (SGOT) / ALT (SGPT) ≤ 3.0 x IULN; if liver metastases, ≤ 5.0 x IULN Serum creatinine ≤ 1.5 x ULN LVEF ≥ 50% performed no more than 4 weeks prior to enrollment. FEV1>50%,mild-moderate pulmonary function dysfunction.
- Able to understand and willing to sign a Human Research Protection Office (HRPO) approved written informed consent document (or that of legally authorized representative, if applicable).
- With good compliance to the treatment and Follow-up
Exclusion Criteria:
- Evidence of small cell, large cell neuroendocrine or carcinoid histology.
- Non-stage IV NSCLC and ECOG performance status 3~5 or KPS<60
- Have a serious or uncontrolled medical condition that could compromise the patients' ability to adhere to the protocol.
- Malignant pleural effusion and pericardial effusion
- Uncontrolled intercurrent illness including, but not limited to, hypertension , diabetes mellitus ,ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding: Patient must have a negative pregnancy test within 14 days of study entry.
- Have a secondary malignancy (except adequately treated non-melanomatous skin cancer, or other cancer such as in situ of the cervix. considered cured by surgical resection or radiation). Patients who have had another malignancy in the past but have been disease free for more than 5 years are eligible.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to EGFR-TKI or other agents used in the study.
- With poor compliance
- The researchers consider it inappropriate to participate in the study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 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:Mutation+ concurrent
IMRT concurrent with EGFR-TKI on paticipants with known sensitive EGFR mutations.
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·EGFR-TKI:gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;
High dose group:DTGTV=70Gy;
Low dose group:DTGTV=50Gy;
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实验性的:Mutation+ concomitant
IMRT concomitant with EGFR-TKI on paticipants with known sensitive EGFR mutations.
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·EGFR-TKI:gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;
High dose group:DTGTV=70Gy;
Low dose group:DTGTV=50Gy;
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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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Therapeutic efficacy of EGFR-TKI and concurrent/concomitant local RT in NSCLC patients.
大体时间:>4 weeks post treatment
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Tumor Response will be evaluated using the RECIST system.
Modified WHO criteria will be used for measurement of tumors.
The irradiated lesion will be excluded from the assessment of response.
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>4 weeks post treatment
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Overall survival (OS)
大体时间:Up to 5 years
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Overall survival is defined as the time interval from date of diagnosis to date of death from any cause
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Up to 5 years
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Progression-free survival (PFS)
大体时间:Up to 5 years
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PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive disease (PD) = at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one or more non-target lesion(s) and/or unequivocal progression of existing non-target lesions |
Up to 5 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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Objective response rate(ORR)
大体时间:Up to 5 years
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Partial response + complete response per RECIST 1.1 criteria Complete response (CR) = disappearance of all target lesions, non-target lesions, and normalization of tumor marker level Partial response (PR) = at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline of sum diameters |
Up to 5 years
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Disease control rate (DCR)
大体时间:Up to 5 years
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Percentage of patients who achieve complete response, partial response, or stable disease per RECIST 1.1 criteria. Complete response (CR) = disappearance of all target lesions, non-target lesions, and normalization of tumor marker level Partial response (PR) = at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline of sum diameters Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Up to 5 years
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不良事件(毒性)
大体时间:长达 5 年
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修订后的 NCI 不良事件通用术语标准 (CTCAE) 4.0 版中的描述和分级量表将用于所有毒性报告。
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长达 5 年
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Local regional progression-free survival(LRPFS)
大体时间:Time Frame: Up to 5 years
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LRPFS is defined as the duration of time from start of treatment to time of progression or recurrence, whichever occurs first..The target lesions is only for primary tumor and regional positive lymph nodes. Progressive disease (PD) = at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one or more target lesion(s) and/or unequivocal progression of existing target lesions. |
Time Frame: Up to 5 years
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合作者和调查者
赞助
调查人员
- 研究主任:Lu Bing, Director、ouyangww103173@163.com
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (预期的)
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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