NCT02938546

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2016

Longer than P75 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

6.2 years

First QC Date

October 17, 2016

Last Update Submit

October 19, 2016

Conditions

Non-small-cell Lung Cancer

Keywords

Non-small-cell lung cancer18F-FDG PET/CTtreatment response assessment

Outcome Measures

Primary Outcomes (1)

  • Glucose metabolism discrepancy of different genotype NSCLC as Assessed by EORTC

    6 years

Secondary Outcomes (1)

  • Different genotype NSCLC metabolic response after treatment as Assessed by EORTC

    6 years

Other Outcomes (1)

  • Time points of predictive specific genotype NSCLC glucose metabolic response by statistics

    6 years

Study Arms (3)

before therapy

ACTIVE COMPARATOR

18F-FDG PET/CT performed before therapy

Radiation: 18F-FDG

3 days after cisplatin chemotherapy and targeted therapy

EXPERIMENTAL

18F-FDG PET/CT performed 3 days after chemotherapy and targeted therapy

Radiation: 18F-FDG

longer time after cisplatin chemotherapy and targeted therapy

EXPERIMENTAL

18F-FDG PET/CT performed before the third cycle chemotherapy and the 7th week targeted therapy

Radiation: 18F-FDG

Interventions

18F-FDGRADIATION

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.

3 days after cisplatin chemotherapy and targeted therapybefore therapylonger time after cisplatin chemotherapy and targeted therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • with diabetes and chest radiotherapy chronic disease; brain metastases patients; with secondary primary maligmant cancer in 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 27690345RESULT

  • 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.

    PMID: 27683031RESULT

  • 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.

    PMID: 27710970RESULT

  • 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.

    PMID: 27236466RESULT

  • 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.

    PMID: 25783515RESULT

  • 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.

    PMID: 19487962RESULT

  • 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.

    PMID: 21617977RESULT

  • 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.

    PMID: 26703796RESULT

  • 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.

    PMID: 27659017RESULT

  • 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.

    PMID: 22326218RESULT

  • 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.

    PMID: 27153497RESULT

  • 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.

    PMID: 27607176RESULT

  • 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.

    PMID: 27729297RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Wenhui Xie, PHD

    Shanghai Chest Hospital of Shanghai Jiao Tong University

    STUDY DIRECTOR

Central Study Contacts

Wenhui Xie, PHD

CONTACT

+8618017321597xknuclear@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

October 21, 2016

Record last verified: 2016-10