Back to resultsMaintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer
Primary Purpose
Stage IV Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SBRT+TKI
TKI
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have biopsy proven metastatic NSCLC (Stage IV).
- Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
- Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response.
- Age 18 to 75 years old.
- Patients must have measurable disease at baseline.
- The amount of metastatic focus <5.
- ECOG score 0-2
- Adequate normal organ and marrow function for TKI treatment and radiotherapy.
- Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)
- Patients must provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients who previously received radiotherapy to the primary site.
- Patient can't tolerate radiotherapy or targeted therapy;
- Pregnant or nursing women
Sites / Locations
- Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SBRT plus TKI group
TKI treatment group
Arm Description
SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment
Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid
Outcomes
Primary Outcome Measures
PFS
Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause
Secondary Outcome Measures
OS
Overall survival: From the first administration to death from any cause
Full Information
NCT ID
NCT03595644
First Posted
June 19, 2018
Last Updated
April 5, 2021
Sponsor
Tongji Hospital
Collaborators
Wuhan Union Hospital, China, Renmin Hospital of Wuhan University, Wuhan University, Hubei Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03595644
Brief Title
Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer
Official Title
Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2017 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
December 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tongji Hospital
Collaborators
Wuhan Union Hospital, China, Renmin Hospital of Wuhan University, Wuhan University, Hubei Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with a targeted agent such as gefitinib, erlotinib and icotinib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SBRT plus TKI group
Arm Type
Experimental
Arm Description
SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment
Arm Title
TKI treatment group
Arm Type
Active Comparator
Arm Description
Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid
Intervention Type
Radiation
Intervention Name(s)
SBRT+TKI
Intervention Description
Received SBRT after three months after EGFR-TKI treatment
Intervention Type
Drug
Intervention Name(s)
TKI
Intervention Description
Received EGFR-TKI treatment
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause
Time Frame
2 years
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival: From the first administration to death from any cause
Time Frame
3 year
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:
Patients must have biopsy proven metastatic NSCLC (Stage IV).
Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response.
Age 18 to 75 years old.
Patients must have measurable disease at baseline.
The amount of metastatic focus <5.
ECOG score 0-2
Adequate normal organ and marrow function for TKI treatment and radiotherapy.
Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)
Patients must provide written informed consent to participate in the study.
Exclusion Criteria:
Patients who previously received radiotherapy to the primary site.
Patient can't tolerate radiotherapy or targeted therapy;
Pregnant or nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li Zhang, MD,PhD
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28973074
Citation
Iyengar P, Wardak Z, Gerber DE, Tumati V, Ahn C, Hughes RS, Dowell JE, Cheedella N, Nedzi L, Westover KD, Pulipparacharuvil S, Choy H, Timmerman RD. Consolidative Radiotherapy for Limited Metastatic Non-Small-Cell Lung Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2018 Jan 11;4(1):e173501. doi: 10.1001/jamaoncol.2017.3501. Epub 2018 Jan 11.
Results Reference
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PubMed Identifier
27789196
Citation
Gomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24.
Results Reference
background
PubMed Identifier
24355488
Citation
de Vin T, Engels B, Gevaert T, Storme G, De Ridder M. Stereotactic radiotherapy for oligometastatic cancer: a prognostic model for survival. Ann Oncol. 2014 Feb;25(2):467-71. doi: 10.1093/annonc/mdt537. Epub 2013 Dec 18.
Results Reference
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Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer
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