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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661567
Recruitment Status : Unknown
Verified September 2018 by Hui Liu, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : September 7, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hui Liu, Sun Yat-sen University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 9, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. the rate of grade≥2 pulmonary ventilation and diffusion capacity decline [ Time Frame: 1 year from the end of radiotherapy ]
    It is divided into grade 1-4 according to SOMA.

  2. the rate of grade≥2 visible change in CT after radiation [ Time Frame: 1 year from the end of radiotherapy ]
    It is divided into grade 1-4 according to SOMA.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 0-1.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661567


Contacts
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Contact: Bo Qiu, Attending +86-020-87343031 qiubo@sysucc.org.cn
Contact: Hui liu, Professor

Locations
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China, Guangdong
Sun yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Bo Qiu, Attending    +86-020-87343031    qiubo@sysucc.org.cn   
Contact: Hui Liu, Professor         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Hui Liu, Professor Sun Yat-sen University
More Information
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Publications:

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Responsible Party: Hui Liu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03661567    
Other Study ID Numbers: GASTO-1044
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui Liu, Sun Yat-sen University:
methylprednisolone
Split-course Chemoradiotherapy
Radiation-induced Pulmonary Injury
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
 Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents