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This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.
Management of locally advanced non-small cell lung cancer (NSCLC) remains a challenge. Both local relapses and distant metastases are frequent, with 5-year survival of 3-17% for inoperable disease. Staging has historically subdivided stage III disease into clinical stage IIIA, thought to be potentially amenable to surgery, and stage IIIB, treated by defi nitive radiotherapy or radiochemotherapy. This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced NSCLC to address optimal induction strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-operative chemotherapy | Experimental | Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles) |
|
| Pre-operative concurrent chemoradiation therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-operative chemotherapy | Drug | Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the time to recurrence | Every 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pathologic complete response rate and the complete resection rate | Every 4 weeks | |
| To estimate toxicities | Every 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxing He, MD, FACS | Contact | +86-20-83337792 | drjianxing.he@gmail.com | |
| Daoyuan Wang, MD | Contact | +86-20-83337792 | ghealth2008@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianxing He, MD, FACS | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical College | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Pre-operative concurrent chemoradiation therapy | Other | Chemotherapy: Docetaxel 20 mg/m2 + carboplatin area under the curve = 2 on D1 and 8, q3weeks, Pre-Op & Post-Op: 2 cycles (total 4 cycles). Concurrent thoracic radiotherapy: Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx |
|
| 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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