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Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients.
For NSCLC patients with synchronous oligometastases, first line chemotherapy or targeted therapy concurrent with non-salvage radiotherapy on metastatic or primary thoracic tumor contributed a longer progression-free survival than chemotherapy or targeted therapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Definitive Radiotherapy | Experimental | Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) followed by 3D-CRT (three-dimensional conformal radiotherapy) or IMRT (intensity modulated radiotherapy) to primary thoracic foci or remediable oligometastatic focus. |
|
| No Local Definitive Radiotherapy | Active Comparator | Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local Definitive Radiotherapy | Radiation | three-dimensional conformal therapy or intensity modulated radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Refers to the time from randomization to disease progression or death. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local tumor control | From time of randomization to time of progression or death(according to RECIST v1.1 [)](streamdown:incomplete-link) | up to 5 years |
| Oligometastatic foci control | From time of first chemotherapy or targeted therapy to time of progression or death(according to RECIST v1.1) |
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Inclusion Criteria:
(1)Bone marrow: White blood cell (WBC)≥4.0G/L;neutrophile granulocyte (NEU)≥1.5G/L;platelets (PLT)≥100G/L; hemoglobin (HGB)≥9g/L; (2)Liver and kidney: total bilirubin (TBIL), aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.0 × the upper limit of normal (ULN);creatinine≤1.5×ULN; 8.Patient must be willing and able to provide written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoxia Zhu, M.D. | Contact | +862062787696 | zhuxx01@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoxia Zhu | Nanfang Hospital, Southern Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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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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A randomized phase II trial of first line chemotherapy or targeted therapy plus local definitive radiotherapy or not for patients with synchronous oligometastatic non-small cell lung cancer
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| No Local Definitive Radiotherapy | Drug | Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test. |
|
|
| up to 5 years |
| Thoracic Progression Free Survival | From time of first chemotherapy or targeted therapy to time of progression or death | up to 5 years |
| Overall Survival | From time of first chemotherapy or targeted therapy to date of death | up to 5 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |