Methylprednisolone After Split-course Chemoradiotherapy For Bulky Local Advanced None-small Cell Lung Cancer

Study Overview
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Brief Summary
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This Phase II randomized controlled study is to determine the efficacy of the preventively use of methylprednisolone after split-course chemoradiotherapy (CCRT) in locally advanced non-small cell lung cancer with bulky tumor.

Detailed Description
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This study is to determine the efficacy of the preventively use of methylprednisolone after split-course chemoradiotherapy(CCRT) in locally advanced non-small cell lung cancer with bulky tumor. All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy, with one-month break. In the experimental arm, patients were treated with methylprednisolone after the first course of radiation, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days,then 16mg for 7 days, and 8 mg for the last 7 days. Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.

Official Title
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A Prospective, Randomized, Controlled Phase Ⅱ Study of Preventively Use of Methylprednisolone After Split-course Chemoradiotherapy to Reduce the Risk of Radiation-induced Pulmonary Injury For Bulky Local Advanced None-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: chest radiation
* Drug: concurrent chemotherapy
* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic confirmation of NSCLC. Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Unresectable phase IIIA(N2) and IIIB lung cancer confirmed by PET/CT, CT or MRI. Whole lung V20>=35% when giving 60Gy which is the minimum dose of radical irradiation. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Previously treated with chemotherapy or treatment-naive No previous chest radiotherapy, immunotherapy or biotherapy Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL FEV1 >0.8 L CB6 within normal limits patients and their family signed the informed consents Exclusion Criteria: Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ Contraindication for chemotherapy Malignant pleural or pericardial effusion. Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose Women who has the probability of pregnancy without contraception Tendency of hemorrhage In other clinical trials within 30 days Addicted in drugs or alcohol, AIDS patients Uncontrollable seizure or psychotic patients without self-control ability Severe allergy or idiosyncrasy Not suitable for this study judged by researchers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone<br>Patients were treated with methylprednisolone after the first course of chest radiation and concurrent chemotherapy, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days, then 16mg for 7 days, and 8 mg for the last 7 days. | Radiation: chest radiation<br>* split-course chest radiation<br>Drug: concurrent chemotherapy<br>* weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation<br>Drug: Methylprednisolone<br>* Methylprednisolone after the first course of radiation, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days, then 16mg for 7 days, and 8 mg for the last 7 days.<br>|
| Active Comparator: Observation<br>Observation after the first course of chest radiation, methylprednisolone can only be used for therapeutic purpose in the presence of grade≥2 radiation induced lung injury(NCI-CTC4.0). | Radiation: chest radiation<br>* split-course chest radiation<br>Drug: concurrent chemotherapy<br>* weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of grade≥2 radiation pneumonia(NCI-CTC4.0) | radiation-induced pulmonary injury is classified into 1-5 grades according to NCI-CTC4.0. The incidence of symptomatic radiation-induced pulmonary injury: the ratio of grade 2 and above radiation-induced pulmonary injury cases in 1 year after radio therapy to all cases can be evaluated . | 1 year from the end of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of grade≥2 pulmonary ventilation and diffusion capacity decline | It is divided into grade 1-4 according to SOMA. | 1 year from the end of radiotherapy | 
| the rate of grade≥2 visible change in CT after radiation | It is divided into grade 1-4 according to SOMA. | 1 year from the end of radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methylprednisolone, Split-course Chemoradiotherapy, Radiation-induced Pulmonary Injury