Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer
Primary Purpose
Carcinoma, Non-Small-Cell Lung, Stage IV, Thoracic Radiotherapy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aggressive Thoracic Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
Inclusion Criteria:
- histologically or cytologically confirmed NSCLC
- stage IV disease
- no progression after first line systemic therapy
- 18 to 80 years of age
- Karnofsky performance status(KPS) score ≥70%
- no contraindications to radiation therapy
- presumed ability to tolerate thoracic radiation therapy to a BED≥53Gy
Exclusion Criteria:
- a history of thoracic surgery, radiation therapy, or more than first line chemotherapy
- pregnancy or lactation at the time of enrollment
- previous malignancy or other concomitant malignant disease
Sites / Locations
- Jiangmen central hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm-R
Arm Description
patients in this arm will receive aggressive thoracic radiotherapy.
Outcomes
Primary Outcome Measures
OS
overall survival
Secondary Outcome Measures
LPFS
local progression free survival
PFS
progression free survival
toxicity related to the radiotherapy
assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03565120
Brief Title
Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer
Official Title
The Efficacy and Toxicity of Aggressive Thoracic Radiotherapy for Stage Ⅳ Non-Small Cell Lung Cancer Patients With Controlled Extrathoracic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
yu gengsheng
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 phase II trial studies the safety and efficacy of aggressive thoracic radiotherapy in treating patients with non-small cell lung cancer that has not progressed after the first line systemic therapy. In this trial, patients with stage Ⅳ non small cell lung cancer who did not progress after first line systemic therapy will receive the aggressive thoracic radiotherapy, and the safety and efficacy of aggressive thoracic radiotherapy will be evaluated. The primary end points of the study are overall survival (OS), the secondary end points are local control rate, local progression free survival(LPFS), PFS, and toxicity and quality of life(QOL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Stage IV, Thoracic Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm-R
Arm Type
Experimental
Arm Description
patients in this arm will receive aggressive thoracic radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Aggressive Thoracic Radiotherapy
Intervention Description
The target of the radiotherapy includes primary tumor and the locoregional positive lymph nodes, with a dose(BED)≥53Gray(Gy)
Primary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
two years after the beginning of first line systemic therapy
Secondary Outcome Measure Information:
Title
LPFS
Description
local progression free survival
Time Frame
1 year after the beginning of first line systemic therapy
Title
PFS
Description
progression free survival
Time Frame
1 year after the beginning of first line systemic therapy
Title
toxicity related to the radiotherapy
Description
assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0
Time Frame
from the beginning of radiotherapy to the 3 month after the completion of radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically or cytologically confirmed NSCLC
stage IV disease
no progression after first line systemic therapy
18 to 80 years of age
Karnofsky performance status(KPS) score ≥70%
no contraindications to radiation therapy
presumed ability to tolerate thoracic radiation therapy to a BED≥53Gy
Exclusion Criteria:
a history of thoracic surgery, radiation therapy, or more than first line chemotherapy
pregnancy or lactation at the time of enrollment
previous malignancy or other concomitant malignant disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li chunming, master
Phone
(+86)07503165905
Email
52212007@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Gengsheng, master
Phone
(+86)07503165915
Email
gengsheng_yu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Gengsheng, master
Organizational Affiliation
jiangmen cenctral hospital
Official's Role
Study Director
Facility Information:
Facility Name
Jiangmen central hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunming LI, master
Phone
+8607503165905
Email
52212007@qq.com
First Name & Middle Initial & Last Name & Degree
Gengsheng Yu, master
Phone
+863165905
Email
gengsheng_yu@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20397921
Citation
Kepka L, Olszyna-Serementa M. Palliative thoracic radiotherapy for lung cancer. Expert Rev Anticancer Ther. 2010 Apr;10(4):559-69. doi: 10.1586/era.10.22.
Results Reference
background
PubMed Identifier
18711191
Citation
Fairchild A, Harris K, Barnes E, Wong R, Lutz S, Bezjak A, Cheung P, Chow E. Palliative thoracic radiotherapy for lung cancer: a systematic review. J Clin Oncol. 2008 Aug 20;26(24):4001-11. doi: 10.1200/JCO.2007.15.3312.
Results Reference
background
PubMed Identifier
26412340
Citation
Koshy M, Malik R, Mahmood U, Rusthoven CG, Sher DJ. Comparative effectiveness of aggressive thoracic radiation therapy and concurrent chemoradiation therapy in metastatic lung cancer. Pract Radiat Oncol. 2015 Nov-Dec;5(6):374-82. doi: 10.1016/j.prro.2015.07.009. Epub 2015 Aug 1.
Results Reference
background
PubMed Identifier
18280058
Citation
Flannery TW, Suntharalingam M, Regine WF, Chin LS, Krasna MJ, Shehata MK, Edelman MJ, Kremer M, Patchell RA, Kwok Y. Long-term survival in patients with synchronous, solitary brain metastasis from non-small-cell lung cancer treated with radiosurgery. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):19-23. doi: 10.1016/j.ijrobp.2007.12.031. Epub 2008 Feb 14.
Results Reference
background
PubMed Identifier
24118842
Citation
Su SF, Hu YX, Ouyang WW, Lu B, Ma Z, Li QS, Li HQ, Geng YC. Overall survival and toxicities regarding thoracic three-dimensional radiotherapy with concurrent chemotherapy for stage IV non-small cell lung cancer: results of a prospective single-center study. BMC Cancer. 2013 Oct 12;13:474. doi: 10.1186/1471-2407-13-474.
Results Reference
background
PubMed Identifier
25216859
Citation
Sheu T, Heymach JV, Swisher SG, Rao G, Weinberg JS, Mehran R, McAleer MF, Liao Z, Aloia TA, Gomez DR. Propensity score-matched analysis of comprehensive local therapy for oligometastatic non-small cell lung cancer that did not progress after front-line chemotherapy. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):850-7. doi: 10.1016/j.ijrobp.2014.07.012. Epub 2014 Sep 9.
Results Reference
background
PubMed Identifier
26720170
Citation
Chiang Y, Yang JC, Hsu FM, Chen YH, Shih JY, Lin ZZ, Lan KH, Cheng AL, Kuo SH. The Response, Outcome and Toxicity of Aggressive Palliative Thoracic Radiotherapy for Metastatic Non-Small Cell Lung Cancer Patients with Controlled Extrathoracic Diseases. PLoS One. 2015 Dec 31;10(12):e0145936. doi: 10.1371/journal.pone.0145936. eCollection 2015.
Results Reference
background
PubMed Identifier
27042220
Citation
Wang J, Ji Z, Wang X, Liang J, Hui Z, Lv J, Zhou Z, Yin W, Wang L. Radical thoracic radiotherapy may provide favorable outcomes for stage IV non-small cell lung cancer. Thorac Cancer. 2016 Mar;7(2):182-9. doi: 10.1111/1759-7714.12305. Epub 2015 Sep 13.
Results Reference
background
PubMed Identifier
27871270
Citation
Su S, Hu Y, Ouyang W, Ma Z, Li Q, Li H, Wang Y, Wang X, Li T, Li J, Chen M, Lu Y, Bai Y, He Z, Lu B. Might radiation therapy in addition to chemotherapy improve overall survival of patients with non-oligometastatic Stage IV non-small cell lung cancer?: Secondary analysis of two prospective studies. BMC Cancer. 2016 Nov 21;16(1):908. doi: 10.1186/s12885-016-2952-3.
Results Reference
background
Learn more about this trial
Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer
We'll reach out to this number within 24 hrs