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| ID | Type | Description | Link |
|---|---|---|---|
| DO210101 |
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The purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine, Nedaplatin,BAI plus 3DCRT | Experimental | Gemcitabine(1000mg/m2),Nedaplatin(60mg/m2),BAI, Day 1/4weeks. 4weeks per cycle. Tumor assessment will be perforemd after 2 cycles. if no PD, patient will be treated with 3DCRTfor 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year.. |
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| Gemcitabine, Nedaplatin, IV Plus 3DCRT | Other | Gemcitabine 100mg/m2, D1 & D8 every 4 weeks Nedaplatin 75mg/m2, D1 every 4 weeks. every 4 weeks per cycle. Tumor assessment will be performed after 2 cycles. if no PD, patient will be treated with 3DCRT for 1 month. for patient PD after 3DCRT, complete the study. patient no PD after 3DCRT will receive 2 cycle of chemo with Gemcitabine. Nedaplatin. then patient will be followed for 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine, Nedaplatin, iV | Drug | Gemcitabine, Injection, 1000mg/m2, D1 & D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Regular tumour assessments (based on RECIST criteria) for determining disease response and progression using CT and MRI scans, and overall survival.The primary efficacy variable is progression free survival (PFS), defined as the time between randomisation and the date of first documented disease progression or death from any cause, whichever comes first. Disease progression is defined according to the RECIST criteria. | every 2 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | after Progressive Disease, patient will be contact every 3 month for the survival information. | every 3 month after Progressive Disease |
| Time to Progressive Disease (RECIST Criteria) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YI LI | Contact | +86-113452081471 | tumordoctor@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 3rd Affiliated Hospital of the 3rd Military Hospital | Recruiting | Chongqing | China |
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| 3DCRT | Radiation | non-PD Patient will be treated with 3DCRT after 2 cycles of chemo. |
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| 3DCRT | Radiation | non-PD Patient will be treated with 3DCRT after 2 cycles of chemo. |
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| Gemcitabine,Nedaplatin, BAI | Drug | Drug: Gemcitabine, Nedaplatin, iV Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI |
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Regular tumour assessments (based on RECIST criteria) for determining disease response and progression using CT and MRI scans.Time to Progression (TTP) is defined as the time between randomisation and the date of the first documented disease progression.
| Every 2 cycles |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C053989 | nedaplatin |
| D061006 | Bays |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009792 | Oceans and Seas |
| D055593 | Geological Phenomena |
| D055585 | Physical Phenomena |
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