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
Overview
- Phase
- Phase 2
- Intervention
- chest radiation
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Hui Liu
Professor
Sun Yat-sen University
Eligibility Criteria
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-
- •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
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
Arms & Interventions
Methylprednisolone
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.
Intervention: chest radiation
Methylprednisolone
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.
Intervention: concurrent chemotherapy
Methylprednisolone
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.
Intervention: Methylprednisolone
Observation
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).
Intervention: chest radiation
Observation
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).
Intervention: concurrent chemotherapy
Outcomes
Primary Outcomes
rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
Time Frame: 1 year from the end of radiotherapy
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 .
Secondary Outcomes
- the rate of grade≥2 pulmonary ventilation and diffusion capacity decline(1 year from the end of radiotherapy)
- the rate of grade≥2 visible change in CT after radiation(1 year from the end of radiotherapy)