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

Lung Adenocarcinoma Patients With Postoperative in pN2 Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02132143
• Other study ID #: LH-2014-XW
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2014
• Last updated: May 5, 2015
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: May 2015
• Source: People's Hospital of Guangxi
• Contact: Hui Lin, Doctor
• Phone: 8613878133622
• Email: linhui33266[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Adenocarcinoma Patients With Postoperative in pN2
• Lung Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning Shi

Sponsors (1)

Lead Sponsor	Collaborator
Hui Lin

Country where clinical trial is conducted

China, 

Outcome

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