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

Hui Lin

Status: Unknown

Conditions: Lung Adenocarcinoma Patients With Postoperative in pN2

Treatments: Radiation: intensity-modulated radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02132143

LH-2014-XW

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Progression-free survival&Concurrent chemoradiotherapy

Experimental group

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.

Treatment:

Radiation: intensity-modulated radiation

Radiation: intensity-modulated radiation

Progression-free survival&sequential chemoradiotherapy

Active Comparator group

Description:

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.

Treatment:

Radiation: intensity-modulated radiation

Radiation: intensity-modulated radiation