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This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection
This Phase II randomized study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locoregional recurrence of non-small cell lung cancer after surgical resection.
Patients received four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 40-51 Gy/10-17 fractions and 15-24 Gy/5-8 fractions administered in the first and second courses, respectively, with one-month break. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| split-course radiotherapy | Experimental | The radiotherapy is delivered using simultaneous integrated boost (SIB)-IMRT. Patients are irradiation at a palliative dose at the initial course: 40-51Gy/10-17f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 15-24 Gy/5-8f is delivered to the residue tumor. Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| split-course radiotherapy | Radiation | split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 2 years | |
| Response Rate | 2 years | |
| rate of patients who develop local recurrence or distant recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Qiu, attending | Contact | +86-020-87343031 | qiubo@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hui Liu, professor | Sun yat-sen universtiy cancer center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hui Liu | Recruiting | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17762336 | Background | Goldstraw P, Crowley J, Chansky K, Giroux DJ, Groome PA, Rami-Porta R, Postmus PE, Rusch V, Sobin L; International Association for the Study of Lung Cancer International Staging Committee; Participating Institutions. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol. 2007 Aug;2(8):706-14. doi: 10.1097/JTO.0b013e31812f3c1a. | |
| 19252018 |
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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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| concurrent chemotherapy | Drug | weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation |
|
| 2 year |
| rate of grade 3-4 radiation pneumonitis/esophagitis evaluated by Common Terminology Criteria for Adverse Events Version 4.0 | 1 year |
| Background |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |