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

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
chest radiation
concurrent chemotherapy
Methylprednisolone
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring methylprednisolone, Split-course Chemoradiotherapy, Radiation-induced Pulmonary Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sun yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methylprednisolone

Observation

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
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
It is divided into grade 1-4 according to SOMA.
the rate of grade≥2 visible change in CT after radiation
It is divided into grade 1-4 according to SOMA.

Full Information

First Posted
September 1, 2018
Last Updated
November 25, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03661567
Brief Title
Methylprednisolone After Split-course Chemoradiotherapy For Bulky Local Advanced None-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
methylprednisolone, Split-course Chemoradiotherapy, Radiation-induced Pulmonary Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone
Arm Type
Experimental
Arm Description
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.
Arm Title
Observation
Arm Type
Active Comparator
Arm Description
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 Type
Radiation
Intervention Name(s)
chest radiation
Intervention Description
split-course chest radiation
Intervention Type
Drug
Intervention Name(s)
concurrent chemotherapy
Intervention Description
weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
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.
Primary Outcome Measure Information:
Title
rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
Description
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 .
Time Frame
1 year from the end of radiotherapy
Secondary Outcome Measure Information:
Title
the rate of grade≥2 pulmonary ventilation and diffusion capacity decline
Description
It is divided into grade 1-4 according to SOMA.
Time Frame
1 year from the end of radiotherapy
Title
the rate of grade≥2 visible change in CT after radiation
Description
It is divided into grade 1-4 according to SOMA.
Time Frame
1 year from the end of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 0-1. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25854336
Citation
Giridhar P, Mallick S, Rath GK, Julka PK. Radiation induced lung injury: prediction, assessment and management. Asian Pac J Cancer Prev. 2015;16(7):2613-7. doi: 10.7314/apjcp.2015.16.7.2613.
Results Reference
background
PubMed Identifier
20171521
Citation
Marks LB, Bentzen SM, Deasy JO, Kong FM, Bradley JD, Vogelius IS, El Naqa I, Hubbs JL, Lebesque JV, Timmerman RD, Martel MK, Jackson A. Radiation dose-volume effects in the lung. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S70-6. doi: 10.1016/j.ijrobp.2009.06.091.
Results Reference
background
PubMed Identifier
14967431
Citation
Barthelemy-Brichant N, Bosquee L, Cataldo D, Corhay JL, Gustin M, Seidel L, Thiry A, Ghaye B, Nizet M, Albert A, Deneufbourg JM, Bartsch P, Nusgens B. Increased IL-6 and TGF-beta1 concentrations in bronchoalveolar lavage fluid associated with thoracic radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):758-67. doi: 10.1016/S0360-3016(03)01614-6.
Results Reference
background
PubMed Identifier
14751516
Citation
Trott KR, Herrmann T, Kasper M. Target cells in radiation pneumopathy. Int J Radiat Oncol Biol Phys. 2004 Feb 1;58(2):463-9. doi: 10.1016/j.ijrobp.2003.09.045.
Results Reference
background
PubMed Identifier
8460855
Citation
Roberts CM, Foulcher E, Zaunders JJ, Bryant DH, Freund J, Cairns D, Penny R, Morgan GW, Breit SN. Radiation pneumonitis: a possible lymphocyte-mediated hypersensitivity reaction. Ann Intern Med. 1993 May 1;118(9):696-700. doi: 10.7326/0003-4819-118-9-199305010-00006.
Results Reference
background
PubMed Identifier
28512460
Citation
Kainthola A, Haritwal T, Tiwari M, Gupta N, Parvez S, Tiwari M, Prakash H, Agrawala PK. Immunological Aspect of Radiation-Induced Pneumonitis, Current Treatment Strategies, and Future Prospects. Front Immunol. 2017 May 2;8:506. doi: 10.3389/fimmu.2017.00506. eCollection 2017.
Results Reference
background
PubMed Identifier
15001271
Citation
Murshed H, Liu HH, Liao Z, Barker JL, Wang X, Tucker SL, Chandra A, Guerrero T, Stevens C, Chang JY, Jeter M, Cox JD, Komaki R, Mohan R. Dose and volume reduction for normal lung using intensity-modulated radiotherapy for advanced-stage non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2004 Mar 15;58(4):1258-67. doi: 10.1016/j.ijrobp.2003.09.086. Erratum In: Int J Radiat Oncol Biol Phys. 2004 Jul 1;59(3):921. Change, Joe T [corrected to Chang, Joe T].
Results Reference
background
PubMed Identifier
21532501
Citation
Gielda BT, Marsh JC, Zusag TW, Faber LP, Liptay M, Basu S, Warren WH, Fidler MJ, Batus M, Abrams RA, Bonomi P. Split-course chemoradiotherapy for locally advanced non-small cell lung cancer: a single-institution experience of 144 patients. J Thorac Oncol. 2011 Jun;6(6):1079-86. doi: 10.1097/JTO.0b013e3182199a7c.
Results Reference
background
PubMed Identifier
29467890
Citation
Li Y, Wang J, Tan L, Hui B, Ma X, Yan Y, Xue C, Shi X, Drokow EK, Ren J. Dosimetric comparison between IMRT and VMAT in irradiation for peripheral and central lung cancer. Oncol Lett. 2018 Mar;15(3):3735-3745. doi: 10.3892/ol.2018.7732. Epub 2018 Jan 4.
Results Reference
background
PubMed Identifier
19327915
Citation
Spoelstra FO, Pantarotto JR, van Sornsen de Koste JR, Slotman BJ, Senan S. Role of adaptive radiotherapy during concomitant chemoradiotherapy for lung cancer: analysis of data from a prospective clinical trial. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1092-7. doi: 10.1016/j.ijrobp.2008.12.027. Epub 2009 Mar 26.
Results Reference
background
PubMed Identifier
11172945
Citation
Inoue A, Kunitoh H, Sekine I, Sumi M, Tokuuye K, Saijo N. Radiation pneumonitis in lung cancer patients: a retrospective study of risk factors and the long-term prognosis. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):649-55. doi: 10.1016/s0360-3016(00)00783-5.
Results Reference
background
PubMed Identifier
22950387
Citation
Vogelius IR, Bentzen SM. A literature-based meta-analysis of clinical risk factors for development of radiation induced pneumonitis. Acta Oncol. 2012 Nov;51(8):975-83. doi: 10.3109/0284186X.2012.718093. Epub 2012 Sep 5.
Results Reference
background
PubMed Identifier
24744681
Citation
Wang LP, Wang YW, Wang BZ, Sun GM, Wang XY, Xu JL. Expression of interleukin-17A in lung tissues of irradiated mice and the influence of dexamethasone. ScientificWorldJournal. 2014 Mar 12;2014:251067. doi: 10.1155/2014/251067. eCollection 2014.
Results Reference
background
PubMed Identifier
25276362
Citation
Kim S, Oh IJ, Park SY, Song JH, Seon HJ, Kim YH, Yoon SH, Yu JY, Lee BR, Kim KS, Kim YC. Corticosteroid therapy against treatment-related pulmonary toxicities in patients with lung cancer. J Thorac Dis. 2014 Sep;6(9):1209-17. doi: 10.3978/j.issn.2072-1439.2014.07.16.
Results Reference
background
PubMed Identifier
20413191
Citation
Guilhem A, Celton B, Terminet A, Pavio C, Raschilas F, Blain H. [Radiation pneumonitis: a rare and potentially severe pneumonia. Usefulness of corticosteroids]. Rev Med Interne. 2010 Aug;31(8):e10-2. doi: 10.1016/j.revmed.2009.08.011. Epub 2010 Apr 21. French.
Results Reference
background
PubMed Identifier
16820236
Citation
Sekine I, Sumi M, Ito Y, Nokihara H, Yamamoto N, Kunitoh H, Ohe Y, Kodama T, Saijo N, Tamura T. Retrospective analysis of steroid therapy for radiation-induced lung injury in lung cancer patients. Radiother Oncol. 2006 Jul;80(1):93-7. doi: 10.1016/j.radonc.2006.06.007. Epub 2006 Jul 3.
Results Reference
background

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

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