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This is a perspective, multicenter,randomized controlled trial to compare the efficacy and safety of radiotherapy Based on PET/CT and IMRT combined with concurrent chemotherapy in patients with locally advanced non small cell lung cancer . Analyses of overall survival (OS) will be done as defined in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Adaptive radiotherapy | Experimental | GTV dose per fraction will be 2.2-2.4 y per fraction for 20 fractions and PTV dose per fraction will be 2.0 Gy per fraction.Perform PET/CT before radiotherapy and at 36 Gy for treatment response assessment and adaptive plan.Adaptive plan treated at 2.2-3.8 Gy per fraction for GTV and 2.0 Gy for PTV in the final 10 fractions. |
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| Conventional radiotherapy | No Intervention | 2 Gy per fraction for all patient,perform PET/CT before radiotherapy and at 40 Gy for treatment response assessment .Continue treatment to a total dose of 60 Gy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy dose | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 24 months | |
| Objective response rate | 24 months | |
| local control rate |
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Inclusion Criteria:
Histologically or cytologically proven non-small cell lung cancer.
Patients must be clinical AJCC stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease; non-operable disease will be determined by a multidisciplinary treatment team.
Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible if a definitive course of daily fractionated RT is planned.
Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
Serum creatinine within normal institutional limits or a creatinine clearance ≥ 60 ml/min within 2 weeks prior to registration;
The patient must provide study-specific informed consent prior to study entry.
Exclusion Criteria
Any component of small cell lung carcinoma.
Evidence of a malignant pleural or pericardial effusion .
Prior invasive malignancy (except nonmelanomatous skin cancer) in 3 years ;
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
Pregnancy or women of childbearing potential and men who are sexually active and not willing to use medically acceptable forms of contraception.
Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) ;
Patients with T4 disease with radiographic evidence of massive invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinming Yu, Ph.D , M.D | Contact | 13806406293 | sdyujinming@126.com | |
| Shuanghu Yuan, Ph.D , M.D | Contact | 13853106916 | yuanshuanghu@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuanghu Yuan, Ph.D , M.D | Shandong Cancer Hospital and Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | China |
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| 24 months |
| Fujian Province Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350008 | China |
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| the First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
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| Liuzhou worker's hospital | Not yet recruiting | Liuzhou | Guangxi | China |
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| Fourth hospital of hebei medical university | Not yet recruiting | Shijiazhuang | Hebei | China |
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| the second Hospital of hebei medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| The Affiliated tumour Hospital of haerbin Medical University | Recruiting | Haerbin | Heilongjiang | China |
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| The Affiliated Cancer Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
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| Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
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| Hubei Provincial Renmin Hospital | Not yet recruiting | Wuhan | Hubei | China |
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| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | China |
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| Qianfoshan Hospital of Shandong | Not yet recruiting | Jinan | Shandong | 250117 | China |
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| Shandong Cancer Hospital and Institute | Recruiting | Jinan | Shandong | China |
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| The affiliated hospital of qingdao university | Not yet recruiting | Qingdao | Shandong | China |
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| Teng Zhou Central People's Hospital | Not yet recruiting | Tengzhou | Shandong | China |
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| Yantai Yuhuangding Hospital | Not yet recruiting | Yantai | Shandong | China |
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| Shanghai Chest Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Xijing hopital | Not yet recruiting | Xi’an | Shanxi | China |
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| the Affiliated Hospital of southwest medicalUniversity | Not yet recruiting | Luzhou | Sichuan | China |
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| The Affiliated Tumor Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | China |
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| The First People's Hospital of Hangzhou | Not yet recruiting | Hangzhou | Zhejiang | 310006 | China |
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| The First Affiliated Hospital of Medical School of Zhejiang University | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| the First Affiliated Hospital of wenzhou medical University | Not yet recruiting | Wenzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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