18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study
Primary Purpose
Non-small-cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
18F-FDG
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-small-cell Lung Cancer focused on measuring Non-small-cell lung cancer, 18F-FDG PET/CT, treatment response assessment
Eligibility Criteria
Inclusion Criteria:
- pathological biopsy for NSCLC; stage III-IV; plan to palliative chemotherapy (such as neoadjuvant chemotherapy, convention and targeted therapy) due to unable to surgery; not radiation therapy or chemotherapy for 6 months before enrollment; the predictive survival time more than half year;
Exclusion Criteria:
- with diabetes and chest radiotherapy chronic disease; brain metastases patients; with secondary primary maligmant cancer in 5 years
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
before therapy
3 days after cisplatin chemotherapy and targeted therapy
longer time after cisplatin chemotherapy and targeted therapy
Arm Description
18F-FDG PET/CT performed before therapy
18F-FDG PET/CT performed 3 days after chemotherapy and targeted therapy
18F-FDG PET/CT performed before the third cycle chemotherapy and the 7th week targeted therapy
Outcomes
Primary Outcome Measures
Glucose metabolism discrepancy of different genotype NSCLC as Assessed by EORTC
Secondary Outcome Measures
Different genotype NSCLC metabolic response after treatment as Assessed by EORTC
Full Information
NCT ID
NCT02938546
First Posted
October 17, 2016
Last Updated
October 19, 2016
Sponsor
Shanghai Chest Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02938546
Brief Title
18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study
Official Title
18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.
Detailed Description
Non-small-cell lung cancer (NSCLC) is the first leading cause of cancer death in the world. Systemic chemotherapy has contributed to the only choice for more than 50% NSCLC patients. The genetic abnormalities lead to different therapy response to the same chemotherapy scheme in NSCLC patients. At present, early assessment and prediction is the key for optimize NSCLC therapy. 18F-FDG PET/CT is a noninvasive cell metabolism reaction molecular imaging technology which can assess cancer glucose metabolism sensitively and react cancer proliferation to some degree. Hence 18F-FDG PET/CT may be used to assess NSCLC therapy response noninvasively. It is a reliable method to individualize NSCLC treatment clinically by define the appropriate metabolism response cut-off values and assess time points of 18F-FDG PET/CT in predicting different genetic NSCLC patients.The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.
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
Non-small-cell lung cancer, 18F-FDG PET/CT, treatment response assessment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
before therapy
Arm Type
Active Comparator
Arm Description
18F-FDG PET/CT performed before therapy
Arm Title
3 days after cisplatin chemotherapy and targeted therapy
Arm Type
Experimental
Arm Description
18F-FDG PET/CT performed 3 days after chemotherapy and targeted therapy
Arm Title
longer time after cisplatin chemotherapy and targeted therapy
Arm Type
Experimental
Arm Description
18F-FDG PET/CT performed before the third cycle chemotherapy and the 7th week targeted therapy
Intervention Type
Radiation
Intervention Name(s)
18F-FDG
Intervention Description
18FDG-PET scan was performed 4 weeks before the first administration of therapy or before the third cycle chemotherapy or before the 7th week of targeted therapy and after 3 days chemotherapy and targeted therapy. The lesions were analyzed by nuclear medicine physician and calculate the metabolism response. The size of percent changes was evaluated using the EORTC (European Organization for Research and Treatment of Cancer) PET criteria by oncologist who determine whether the scheme works and the scheme should continue or change. The seleted patients were double blinded to analyse the relationship between metabolism response and chemotherapy response.
Primary Outcome Measure Information:
Title
Glucose metabolism discrepancy of different genotype NSCLC as Assessed by EORTC
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Different genotype NSCLC metabolic response after treatment as Assessed by EORTC
Time Frame
6 years
Other Pre-specified Outcome Measures:
Title
Time points of predictive specific genotype NSCLC glucose metabolic response by statistics
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pathological biopsy for NSCLC; stage III-IV; plan to palliative chemotherapy (such as neoadjuvant chemotherapy, convention and targeted therapy) due to unable to surgery; not radiation therapy or chemotherapy for 6 months before enrollment; the predictive survival time more than half year;
Exclusion Criteria:
with diabetes and chest radiotherapy chronic disease; brain metastases patients; with secondary primary maligmant cancer in 5 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhui Xie, PHD
Phone
+8618017321597
Email
xknuclear@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhui Xie, PHD
Organizational Affiliation
Shanghai Chest Hospital, Shanghai Jiao Tong University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27690345
Citation
Zhao Y, Wang H, Shi Y, Cai S, Wu T, Yan G, Cheng S, Cui K, Xi Y, Qi X, Zhang J, Ma W. Comparative effectiveness of combined therapy inhibiting EGFR and VEGF pathways in patients with advanced non-small-cell lung cancer: a meta-analysis of 16 phase II/III randomized trials. Oncotarget. 2017 Jan 24;8(4):7014-7024. doi: 10.18632/oncotarget.12294.
Results Reference
result
PubMed Identifier
27683031
Citation
Zhang T, Xie J, Arai S, Wang L, Shi X, Shi N, Ma F, Chen S, Huang L, Yang L, Ma W, Zhang B, Han W, Xia J, Chen H, Zhang Y. The efficacy and safety of anti-PD-1/PD-L1 antibodies for treatment of advanced or refractory cancers: a meta-analysis. Oncotarget. 2016 Nov 8;7(45):73068-73079. doi: 10.18632/oncotarget.12230.
Results Reference
result
PubMed Identifier
27710970
Citation
Watanabe K, Shinkai M, Tei Y, Kaneko T. Chemotherapy in Non-Small Cell Lung Cancer Patients Receiving Oxygen Therapy. Oncol Res Treat. 2016;39(10):587-590. doi: 10.1159/000449328. Epub 2016 Sep 15.
Results Reference
result
PubMed Identifier
27236466
Citation
Shang J, Ling X, Zhang L, Tang Y, Xiao Z, Cheng Y, Guo B, Gong J, Huang L, Xu H. Comparison of RECIST, EORTC criteria and PERCIST for evaluation of early response to chemotherapy in patients with non-small-cell lung cancer. Eur J Nucl Med Mol Imaging. 2016 Oct;43(11):1945-53. doi: 10.1007/s00259-016-3420-7. Epub 2016 May 28.
Results Reference
result
PubMed Identifier
25783515
Citation
Ho TY, Chou PC, Yang CT, Tsang NM, Yen TC. Total lesion glycolysis determined per RECIST 1.1 criteria predicts survival in EGFR mutation-negative patients with advanced lung adenocarcinoma. Clin Nucl Med. 2015 Jun;40(6):e295-9. doi: 10.1097/RLU.0000000000000774.
Results Reference
result
PubMed Identifier
19487962
Citation
Lee DH, Kim SK, Lee HY, Lee SY, Park SH, Kim HY, Kang KW, Han JY, Kim HT, Lee JS. Early prediction of response to first-line therapy using integrated 18F-FDG PET/CT for patients with advanced/metastatic non-small cell lung cancer. J Thorac Oncol. 2009 Jul;4(7):816-21. doi: 10.1097/JTO.0b013e3181a99fde.
Results Reference
result
PubMed Identifier
21617977
Citation
Huang W, Zhou T, Ma L, Sun H, Gong H, Wang J, Yu J, Li B. Standard uptake value and metabolic tumor volume of (1)(8)F-FDG PET/CT predict short-term outcome early in the course of chemoradiotherapy in advanced non-small cell lung cancer. Eur J Nucl Med Mol Imaging. 2011 Sep;38(9):1628-35. doi: 10.1007/s00259-011-1838-5. Epub 2011 May 27.
Results Reference
result
PubMed Identifier
26703796
Citation
Wijesinghe P, Bollig-Fischer A. Lung Cancer Genomics in the Era of Accelerated Targeted Drug Development. Adv Exp Med Biol. 2016;890:1-23. doi: 10.1007/978-3-319-24932-2_1.
Results Reference
result
PubMed Identifier
27659017
Citation
Tafe LJ, Pierce KJ, Peterson JD, de Abreu F, Memoli VA, Black CC, Pettus JR, Marotti JD, Gutmann EJ, Liu X, Shirai K, Dragnev KH, Amos CI, Tsongalis GJ. Clinical Genotyping of Non-Small Cell Lung Cancers Using Targeted Next-Generation Sequencing: Utility of Identifying Rare and Co-mutations in Oncogenic Driver Genes. Neoplasia. 2016 Sep;18(9):577-83. doi: 10.1016/j.neo.2016.07.010.
Results Reference
result
PubMed Identifier
22326218
Citation
Yuneva MO, Fan TW, Allen TD, Higashi RM, Ferraris DV, Tsukamoto T, Mates JM, Alonso FJ, Wang C, Seo Y, Chen X, Bishop JM. The metabolic profile of tumors depends on both the responsible genetic lesion and tissue type. Cell Metab. 2012 Feb 8;15(2):157-70. doi: 10.1016/j.cmet.2011.12.015.
Results Reference
result
PubMed Identifier
27153497
Citation
Masri S, Papagiannakopoulos T, Kinouchi K, Liu Y, Cervantes M, Baldi P, Jacks T, Sassone-Corsi P. Lung Adenocarcinoma Distally Rewires Hepatic Circadian Homeostasis. Cell. 2016 May 5;165(4):896-909. doi: 10.1016/j.cell.2016.04.039.
Results Reference
result
PubMed Identifier
27607176
Citation
Dejust S, Morland D, Fabre G, Prevost A, Papathanassiou D. 18F-FDG PET/CT Evaluation of Ceritinib Therapy in Metastatic ALK-Positive Non-small Cell Lung Cancer. Clin Nucl Med. 2016 Nov;41(11):879-880. doi: 10.1097/RLU.0000000000001361.
Results Reference
result
PubMed Identifier
27729297
Citation
Manegold C, Dingemans AC, Gray JE, Nakagawa K, Nicolson M, Peters S, Reck M, Wu YL, Brustugun OT, Crino L, Felip E, Fennell D, Garrido P, Huber RM, Marabelle A, Moniuszko M, Mornex F, Novello S, Papotti M, Perol M, Smit EF, Syrigos K, van Meerbeeck JP, van Zandwijk N, Yang JC, Zhou C, Vokes E. The Potential of Combined Immunotherapy and Antiangiogenesis for the Synergistic Treatment of Advanced NSCLC. J Thorac Oncol. 2017 Feb;12(2):194-207. doi: 10.1016/j.jtho.2016.10.003. Epub 2016 Oct 8.
Results Reference
result
Learn more about this trial
18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study
We'll reach out to this number within 24 hrs