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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mutation+ concurrent | Experimental | IMRT concurrent with EGFR-TKI on paticipants with known sensitive EGFR mutations. |
|
| Mutation+ concomitant | Experimental | IMRT concomitant with EGFR-TKI on paticipants with known sensitive EGFR mutations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGFR-TK Inhibitor | Drug | ·EGFR-TKI:gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic efficacy of EGFR-TKI and concurrent/concomitant local RT in NSCLC patients. | 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. | >4 weeks post treatment |
| Overall survival (OS) | Overall survival is defined as the time interval from date of diagnosis to date of death from any cause | Up to 5 years |
| Progression-free survival (PFS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | 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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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Bing, Director | Contact | 86-18275356814 | ouyangww103173@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lu Bing, Director | ouyangww103173@163.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The affiliated hospital of Guizhou medical university | Guiyang | Guizhou | 550004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34631535 | Derived | Li Q, Liang N, Zhang X, Zhang Y, Ouyang W, Su S, Ma Z, Hu Y, Geng Y, Chen X, Lu B. Reasonable Timing of Radiotherapy for Stage IV Non-Small-Cell Lung Cancer During Targeted Therapy Based on Tumour Volume Change. Front Oncol. 2021 Sep 23;11:705303. doi: 10.3389/fonc.2021.705303. eCollection 2021. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Intensity Modulated Radiation Therapy | Radiation | High dose group:DTGTV=70Gy;
Low dose group:DTGTV=50Gy;
|
|
| Disease control rate (DCR) | 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 |
| Adverse events (toxicities) | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. | Up to 5 years |
| Local regional progression-free survival(LRPFS) | 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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |