Lung Adenocarcinoma Patients With Postoperative in pN2
Conditions
Keywords
Lung adenocarcinoma, Concurrent chemoradiotherapy, Sequential chemoradiotherapy, Progression-free survival
Brief summary
The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients.
Interventions
RADIATIONintensity-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.
Sponsors
Hui Lin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Lung adenocarcinoma * 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
Exclusion criteria
* Do not meet the inclusion criteria * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | two and a half years | 01/01/2014-06/01/2016 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | two and a half years | 01/01/2014-01/01-2016 |
Other
| Measure | Time frame | Description |
|---|---|---|
| side-effect | one year | 06/01/2014-06/01/2015 |
Countries
China
Contacts
Primary ContactHui Lin, Doctor
Backup ContactJiao Yang, Master
Outcome results
None listed