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Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard of care for patients with inoperable stage III NSCLC. The most common chemotherapeutic agents used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in conjunction with cisplatin or weekly paclitaxel and carboplatin. No randomized phase III trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen over another. The clinical trial is to compare radiotherapy concurrently with PE (etoposide and cisplatin) and PC (paclitaxel and carbplatin) for local advanced NSCLC (stage IIIA/IIIB). It is a randomized, multicenter, open labeled phase III clinical trial. All patients receive conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. The chemotherapy regimens are PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 ) and PC (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over 30min weekly). The primary purpose is to evaluate objective response rate, complications, progression-free survival, overall survival. The second purpose is to evaluate quality of life and cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PE concurrent chemotherapy | Active Comparator | Radiotherapy concurrently with PE chemotherapy |
|
| PC concurrent chemotherapy | Active Comparator | Radiotherapy concurrently with PC chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoradiotherapy Regimen between PC and PE | Other | etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 during radiotherapy paclitaxel 45mg/m2 weekly and carbplatin AUC =2mg/mL/min weekly during radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| luhua Wang, MD | Department of Radiation Oncology, Cancer Hospital & Institution, CAMS & PUMC | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32252680 | Derived | Bi N, Liu L, Liang J, Wu S, Chen M, Lv C, Zhao L, Shi A, Jiang W, Xu Y, Zhou Z, Wang J, Wang W, Chen D, Hui Z, Lv J, Zhang H, Feng Q, Xiao Z, Wang X, Zhang T, Yin W, Li J, He J, Wang L. Efficacy and safety of concurrent chemoradiotherapy in ECOG 2 patients with locally advanced non-small-cell lung cancer: a subgroup analysis of a randomized phase III trial. BMC Cancer. 2020 Apr 6;20(1):278. doi: 10.1186/s12885-020-06780-x. | |
| 28137739 |
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|
| Derived |
| Liang J, Bi N, Wu S, Chen M, Lv C, Zhao L, Shi A, Jiang W, Xu Y, Zhou Z, Wang W, Chen D, Hui Z, Lv J, Zhang H, Feng Q, Xiao Z, Wang X, Liu L, Zhang T, Du L, Chen W, Shyr Y, Yin W, Li J, He J, Wang L. Etoposide and cisplatin versus paclitaxel and carboplatin with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer: a multicenter randomized phase III trial. Ann Oncol. 2017 Apr 1;28(4):777-783. doi: 10.1093/annonc/mdx009. |
| 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 |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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