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The primary objective is to assess the safety and efficacy of hypofractionated radiotherapy followed by hypo-boost combined with concurrent weekly chemotherapy in unresectable LA-NSCLC patients.
Patients receive four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, concurrent with split-course thoracic radiotherapy of 40 Gy/10 fractions and 28 Gy/7 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)-intensity-modulated radiotherapy (IMRT). Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to gross tumor. 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 re-simulated. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f 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 | Patients are irradiation at a palliative dose at the initial course: 40Gy/10f 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 28Gy/7f is delivered to the residue tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3 years | |
| response rate | 2 months | |
| rate of grade 3-4 radiation esophagitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Liu, Ph.D | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hui Liu | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21296855 | Background | Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. | |
| Background | Schrum D, Carter D, Kelsey C, et al: Non Small Cell Lung Cancer (ed 9). Philadelphia, PA, Lippincott Williams & Wilkins, 2011, pp 799-847. | ||
| 2169587 |
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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 | Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration. |
|
| 1 year |
| rate of grade 3-4 radiation pneumonitis | 1 year |
| Background |
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| 37100160 | Derived | Zhou R, Qiu B, Xiong M, Liu Y, Peng K, Luo Y, Wang D, Liu F, Chen N, Guo J, Zhang J, Huang X, Rong Y, Liu H. Hypofractionated Radiotherapy followed by Hypofractionated Boost with weekly concurrent chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: Results of A Prospective Phase II Study (GASTO-1049). Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):387-399. doi: 10.1016/j.ijrobp.2023.04.021. Epub 2023 Apr 25. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |