Lung Adenocarcinoma Patients With Postoperative in pN2 Clinical Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning Shi |
Lead Sponsor | Collaborator |
---|---|
Hui Lin |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | side-effect | 06/01/2014-06/01/2015 | one year | Yes |
Primary | progression-free survival | 01/01/2014-06/01/2016 | two and a half years | Yes |
Secondary | Overall survival | 01/01/2014-01/01-2016 | two and a half years | Yes |