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To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced non-small lung cancer.
Local failure remains high in patients with locoregionally advanced non-small lung cancer. Given that a biological equivalent dose (BED)more than 100 Gy yields approximately a local control rate of 90% in early-stage non-small lung cancer, this BED or ever higher is logically required to control local disease for locally advanced non-small lung cancer. However, dose escalation is limited by radiation-related toxicity. Use of hyperfractionated radiation Therapy boost to residual metabolic disease as defined by positron emission tomography and computed tomography (PET/CT) immediately after standard chemoradiotherapy (SCRT) using image-guided (IG) IMRT could potentially improve local control and perhaps survival
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose chemoradiotherapy | Experimental | all eligible patients receive image-guided intensity-modulated radiotherapy 60 Gy in 30 fractions over 6 weeks and concurrent weekly paclitaxel and cisplatin,followed by hyperfractionated intensity-modulated radiotherapy boost to residual metabolic disease concurrent with the same chemotherapy regimen, followed by adjuvant chemotherapy 6 weeks after completion of radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high dose chemoradiotherapy | Radiation | Radiation therapy: 60 Gy at 2 Gy/Fx/d over 6 weeks, immediately followed by 28.8 Gy in 24 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 88.8 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 2 and paclitaxel 45 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy is planned 6 weeks after high dose chemoradiation. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival rate | survival time was measured from the date of study enrollment to the date of death or last follow-up | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| toxicities | Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4. | 2 year |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ningning Cheng, MD | Contact | 37798364 | 8119 | ningcnn@163.com |
| Yong Liu, MD | Contact | 37798364 | drliuyrt@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tingfeng Chen, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Genernal Hospital | Recruiting | Shanghai | Shanghai Municipality | 210000 | China |
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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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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |