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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03661567

Collaborator

(none)

234

Enrollment

Location

Arms

36.8

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Radiation: chest radiation Drug: concurrent chemotherapy Drug: Methylprednisolone	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 9, 2018

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Radiation: chest radiation split-course chest radiation Drug: concurrent chemotherapy weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation Drug: Methylprednisolone 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.
Active Comparator: 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).	Radiation: chest radiation split-course chest radiation Drug: concurrent chemotherapy weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

Arm

Intervention/Treatment

Experimental: 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.

Radiation: chest radiation

split-course chest radiation

Drug: concurrent chemotherapy

weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

Drug: Methylprednisolone

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.

Active Comparator: 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).

Radiation: chest radiation

split-course chest radiation

Drug: concurrent chemotherapy

weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation

Outcome Measures

Primary Outcome Measures

rate of grade≥2 radiation pneumonia(NCI-CTC4.0) [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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