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Methylprednisolone After Split-course Chemoradiotherapy For Bulky Local Advanced None-small Cell Lung Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT03661567•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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
+3 more criteria

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
+1 more criteria

Locations (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

August 9, 2018

Primary Completion Date

September 10, 2021

Completion Date

September 10, 2021

Last Updated

November 30, 2022

Enrollment

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

chest radiation

RADIATION

concurrent chemotherapy

DRUG

Methylprednisolone

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)