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Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2

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ClinicalTrials.gov Identifier: NCT02132143
Recruitment Status : Unknown
Verified May 2015 by Hui Lin, People's Hospital of Guangxi.
Recruitment status was:  Recruiting
First Posted : May 7, 2014
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Hui Lin, People's Hospital of Guangxi

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.

Condition or disease Intervention/treatment Phase
Lung Adenocarcinoma Patients With Postoperative in pN2 Radiation: intensity-modulated radiation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Radiation: 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.

Active Comparator: 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.
Radiation: 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.




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: two and a half years ]
    01/01/2014-06/01/2016


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: two and a half years ]
    01/01/2014-01/01-2016


Other Outcome Measures:
  1. side-effect [ Time Frame: one year ]
    06/01/2014-06/01/2015



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132143


Contacts
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Contact: Hui Lin, Doctor 8613878133622 linhui33266@sina.com
Contact: Jiao Yang, Master 8613707872959 yyvsyy6912@163.com

Locations
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China
The People's Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning Shi, China, 530021
Contact: Hui Lin    8613878133266    linhui33266@sina.com   
Sponsors and Collaborators
Hui Lin
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Responsible Party: Hui Lin, The president of the People's Hospital of Guangxi, People's Hospital of Guangxi
ClinicalTrials.gov Identifier: NCT02132143    
Other Study ID Numbers: LH-2014-XW
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Keywords provided by Hui Lin, People's Hospital of Guangxi:
Lung adenocarcinoma
Concurrent chemoradiotherapy
Sequential chemoradiotherapy
Progression-free survival
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site