18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study

NCT ID: NCT02938546

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2023-01-31

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.

Conditions

Non-small-cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

before therapy

18F-FDG PET/CT performed before therapy

Group Type: ACTIVE_COMPARATOR

18F-FDG

Intervention Type: RADIATION

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 therapy

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

Group Type: EXPERIMENTAL

18F-FDG

Intervention Type: RADIATION

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.

longer time after cisplatin chemotherapy and targeted therapy

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

Group Type: EXPERIMENTAL

18F-FDG

Intervention Type: RADIATION

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.

Interventions

18F-FDG

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wenhui XIE

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenhui Xie, PHD

Role: STUDY_DIRECTOR

Shanghai Chest Hospital of Shanghai Jiao Tong University

Central Contacts

Wenhui Xie, PHD

Role: CONTACT

xknuclear@163.com

+8618017321597

References

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.

Reference Type: RESULT

PMID: 27690345 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27683031 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27710970 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27236466 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25783515 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19487962 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21617977 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26703796 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27659017 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22326218 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27153497 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27607176 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27729297 (View on PubMed)

Other Identifiers

WXIE

Identifier Type: -

Identifier Source: org_study_id