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

Primary Purpose

Lung Adenocarcinoma Patients With Postoperative in pN2

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

intensity-modulated radiation

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma Patients With Postoperative in pN2 focused on measuring Lung adenocarcinoma, Concurrent chemoradiotherapy, Sequential chemoradiotherapy, Progression-free survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The People's Hospital of Guangxi Zhuang Autonomous RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progression-free survival&Concurrent chemoradiotherapy

Progression-free survival&sequential chemoradiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

progression-free survival

01/01/2014-06/01/2016

Secondary Outcome Measures

Overall survival

01/01/2014-01/01-2016

Full Information

NCT ID

NCT02132143

First Posted

May 2, 2014

Last Updated

May 5, 2015

Sponsor

Hui Lin

1. Study Identification

Unique Protocol Identification Number

NCT02132143

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hui Lin

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Adenocarcinoma Patients With Postoperative in pN2

Keywords

Lung adenocarcinoma, Concurrent chemoradiotherapy, Sequential chemoradiotherapy, Progression-free survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Progression-free survival&Concurrent chemoradiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Progression-free survival&sequential chemoradiotherapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

intensity-modulated radiation

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

intensity-modulated radiation

Intervention Description

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 Measure Information:

Title

progression-free survival

Description

01/01/2014-06/01/2016

Time Frame

two and a half years

Secondary Outcome Measure Information:

Title

Overall survival

Description

01/01/2014-01/01-2016

Time Frame

two and a half years

Other Pre-specified Outcome Measures:

Title

side-effect

Description

06/01/2014-06/01/2015

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hui Lin, Doctor

Phone

8613878133622

linhui33266@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jiao Yang, Master

Phone

8613707872959

yyvsyy6912@163.com

Facility Information:

Facility Name

The People's Hospital of Guangxi Zhuang Autonomous Region

City

Nanning Shi

ZIP/Postal Code

530021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Lin

Phone

8613878133266

linhui33266@sina.com

12. IPD Sharing Statement

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

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