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

November 25, 2022 updated by: Hui Liu, Sun Yat-sen University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
Drug: concurrent chemotherapy
weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
Radiation: chest radiation
split-course 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).
Drug: concurrent chemotherapy
weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
Radiation: chest radiation
split-course chest radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
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
Time Frame: 1 year from the end of radiotherapy
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
Time Frame: 1 year from the end of radiotherapy
It is divided into grade 1-4 according to SOMA.
1 year from the end of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 9, 2018

Primary Completion (ACTUAL)

September 10, 2021

Study Completion (ACTUAL)

September 10, 2021

Study Registration Dates

First Submitted

September 1, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (ACTUAL)

September 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-1044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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