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The goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin & paclitaxel) in patients with stage III non-small cell lung cancer (NSCLC).
Concurrent chemoradiotherapy is the standard of care for unresectable stage III NSCLC based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 60- Gy at -2 Gy/fraction for nearly four decades (60Gy), with local disease control rates of approximately 50% and a median overall survival of only 18 months.These results are suboptimal and more effective treatment regimens are needed.
We hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiochemotherapy 1 | Experimental | Patients will be treated with radiation therapy 64.8 Gy |
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| radiochemotherapy 2 | Experimental | Patients will be treated with radiation therapy 69.6 Gy |
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| radiochemotherapy 3 | Experimental | Patients will be treated with radiation therapy 74.4 Gy |
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| radiochemotherapy 4 | Experimental | Patients will be treated with radiation therapy 79.2 Gy |
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| radiochemotherapy 5 | Experimental | Patients will be treated with radiation therapy 84 Gy |
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| radiochemotherapy 6 | Experimental | Patients will be treated with radiation therapy 88.8 Gy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiochemotherapy 1 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 60 Gy at 2 Gy/Fx/d, then 4.8 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Local Failure | Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan | 2 years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tingfeng Chen, MD | the ethic committee of shanghai genernal hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Ethic Committee of Shanghai General Hospital | Shanghai | China |
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| radiochemotherapy 7 | Experimental | Patients will be treated with radiation therapy 93.6 Gy |
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| radiochemotherapy 2 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 2: 60 Gy at 2 Gy/Fx/d, then 9.6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly |
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| radiochemotherapy 3 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 3: 60 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly |
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| radiochemotherapy 4 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 4: 60 Gy at 2 Gy/Fx/d, then 19.2 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly |
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| radiochemotherapy 5 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 5: 60 Gy at 2 Gy/Fx/d, then 4.8x5 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly |
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| radiochemotherapy 6 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 6: 60 Gy at 2 Gy/Fx/d, then 4.8x6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly |
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| radiochemotherapy 7 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 7: 60 Gy at 2 Gy/Fx/d, then 4.8x7 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly |
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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 |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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