Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2
NCT ID: NCT02132143
Last Updated: 2015-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2014-01-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Progression-free survival&Concurrent chemoradiotherapy
The first day of radiotherapy given pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, two cycles of chemotherapy given during radiotherapy; then continue to give two cycles of consolidation chemotherapy, 21 days as a cycle.
Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W.
intensity-modulated radiation
For concurrent chemoradiotherapy, the intensity-modulated radiation therapy(IMRT)will be given at the first day of therapy,total dose of 5000cGy～6000cGy/5-6 Weeks.
Progression-free survival&sequential chemoradiotherapy
Patients received adjuvant chemotherapy for four cycles,pemetrexed(Powder for Injection) 500mg/m2 + cisplatin(Powder for Injection) 75mg/m2, 21 days as a cycle.Then accept the Intensity-modulated radiation therapy(IMRT),5000cGy～6000cGy/5～6W.
intensity-modulated radiation
For sequential chemoradiotherapy,the intensity-modulated radiation will(IMRT) will be given when patients received adjuvant chemotherapy for four cycles,total dose of 5000cGy～6000cGy/5-6 Weeks.
Interventions
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intensity-modulated radiation
For concurrent chemoradiotherapy, the intensity-modulated radiation therapy(IMRT)will be given at the first day of therapy,total dose of 5000cGy～6000cGy/5-6 Weeks.
intensity-modulated radiation
For sequential chemoradiotherapy,the intensity-modulated radiation will(IMRT) will be given when patients received adjuvant chemotherapy for four cycles,total dose of 5000cGy～6000cGy/5-6 Weeks.
Eligibility Criteria
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Inclusion Criteria
* Postoperative staging pN2 period
* Voluntary participation and informed consent
* Age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy
* performance status( PS) score 0-2.
* Hemoglobin ≥ 80 g / L, white blood cell ≥ 4 × 109 / L, platelets ≥ 100 × 109 / L.
* Liver function: alanine aminotransferase (ALAT), aspartate transaminase (ASAT) \<upper limit of normal (ULN) of 1.5 times, bilirubin \<1.5 × ULN.
* Renal function: serum creatinine \<1.5 × ULN.
* Compliance, and can be regular follow-up, voluntary compliance with study requirements
* There is evidence of distant metastases
* Suffered from other malignancies in five years
* Within the past January subjects received other drug trials
* Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
* Severe lung or heart disease, a history
* Refuses or is unable to sign informed consent to participate in trials
* The abuse of drugs or alcohol addicts.
* Patients with difficult to control bacterial, viral, fungal infections
* Having a personality or mental disorders, without civil capacity or restricted civil capacity.
* Being pregnant or lactating women.
18 Years
75 Years
ALL
No
Sponsors
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Hui Lin
OTHER
Responsible Party
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Hui Lin
The president of the People's Hospital of Guangxi
Locations
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The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LH-2014-XW
Identifier Type: -
Identifier Source: org_study_id
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