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| Name | Class |
|---|---|
| Mianyang Central Hospital | OTHER |
| Cancer Hospital of Guizhou Province | OTHER |
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This study evaluates the optimal intervention time of radiotherapy for oligometastatic stage iv lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Patients receive concurrent chemoradiotherapy at first。Patients also receive chemotherapy every 3-4 weeks for two cycles after concurrent chemoradiotherapy. chemotherapy:(1) squamous cell carcinoma:Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.(2)non squamous cell carcinoma: pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3. |
|
| Arm B | Active Comparator | Patients receive neoadjuvant chemotherapy every 3-4 weeks for two cycles at first.Patients then receive concurrent chemoradiotherapy after neoadjuvant chemotherapy. chemotherapy:(1) squamous cell carcinoma:Docetaxel 60mg/m2 d1+Cisplatin 25mg/m2 d1-3.(2)non squamous cell carcinoma: pemetrexed 500mg/m2 d1+Cisplatin 25mg/m2 d1-3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| concurrent chemoradiotherapy | Radiation | Radiation(image-guided radiotherapy):(1)primary tumors≤3cm,Hypofractionated radiation therapy,accumulated dose BED ≥80Gy (central lung cancer),BED ≥100Gy(Peripheral lung cancer).(2)primary tumors>3cm,conventional fractionated radiotherapy,accumulated dose BED=60-66Gy/30-33f.(3) regional lymph node:conventional fractionated radiotherapy,accumulated dose BED=60-66Gy/30-33f.(4) Brain metastases: whole brain radiation therapy,36Gy/12f,Intracranial metastases,48Gy/12f.(5) bone metastasis:36 Gy/12f. |
| Measure | Description | Time Frame |
|---|---|---|
| short-term effects(The response rate,RR) | Response Evaluation Criteria In Solid Tumors (RECIST) | 3 months after the end of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| PFS(progression-free survival) | up to 3 years | |
| Quality of life (QOL) | Quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI) and lung cancer subscale (LCS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TAO LI, MD, PhD | Contact | 86-18908178818 | litaoxmf@126.com |
| Name | Affiliation | Role |
|---|---|---|
| JIAHUA LV, MD | Sichuan Cancer Hospital and Research Institute | Principal Investigator |
| XIAOHU WANG, MD, PhD | Gansu Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital & Institute | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Docetaxel | Drug | Docetaxel:60mg/m2 d1,Given IV |
|
| pemetrexed | Drug | pemetrexed: 500mg/m2 d1,Given IV |
|
| Cisplatin | Drug | Cisplatin:25mg/m2 d1-3,Given IV |
|
| up to 3 years |
| esophagitis and pneumonitis | Grade 3-5 esophagitis and pneumonitis adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 | up to 3 years |
| Other grade 3-5 adverse events | Other grade 3-5 adverse events as assessed by NCI CTCAE v3.0 | up to 3 years |
| XIAOBO DU, MD, PhD |
| Mianyang Central Hospital |
| Principal Investigator |
| BING LU, MD.PhD | Cancer Hospital of Guizhou Province | Principal Investigator |
| 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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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| D000077143 | Docetaxel |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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