- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02527057
Diffusion-weighted Magnetic Resonance Imaging (DW-MRI )for Early Response Assessment in Patients With Esophageal Cancer
Diffusion-weighted Magnetic Resonance Imaging(DW-MRI) for Early Response Assessment of Neoadjuvant Chemoradiation Therapy(Neo-CRT) in Patients With Esophageal Squamous Cell Carcinoma(ESCC)
Esophageal carcinoma is a lethal disease, causing more than 400,000 deaths annually worldwide. Primary surgery results in microscopically positive resection margins (R1) in 25% patients, and the 5-year overall survival(OS) for such patients rarely exceeds 40%. Concurrent chemoradiation followed by surgery results in better survival than single-modality treatments, and thus National Comprehensive Cancer Network(NCCN) recommends concurrent chemoradiation as preoperative or definitive treatment for patients with stage II or III esophageal cancer. However, neoadjuvant chemoradiation may not be effective in some subgroup of these patients, and its toxicity can increase perioperative mortality and delay or preclude surgery. The ability to distinguish tumors that will respond or not respond to such therapy remains an urgent priority. Diffusion-weighted magnetic resonance imaging(DW-MRI) is based on the extent of mobility of water protons, as quantified by the apparent diffusion coefficient (ADC). The ADC is a measure of the extent of free diffusion of water molecules within tissues, which is mainly influenced by cell organization, size, and density. Cell death leads to a loss of cell membrane integrity and density and leads to increases in ADC values. The ADC has emerged as a potential biomarker of response to cancer therapy. However, no one has published findings regarding the potential correlation between changes in ADC and response of esophageal cancer to chemoradiation. Clarifying the potential predictive value of DW-MRI for predicting response to such therapy is important for the delivery of appropriately tailored treatment.
Investigators hypothesized that DW-MRI can predict the success (or failure) of neoadjuvant chemoradiation in esophageal squamous cell carcinoma(ESCC), hence identify patients at high risk of treatment failure from such therapy. Investigators will test this hypothesis with two specific aims: (1) assess the ability of ADC to predict pathologic response to treatment; and (2) assess the ability of ADC to predict disease-free survival and overall survival.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Hunan
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Changsha, Hunan, Kina
- Rekrytering
- Hunan province tumor pospital
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Kontakt:
- shengqi wu, M.D.
- Telefonnummer: 13807316075
- E-post: wushengqi@hnszlyy.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- T1bN+ M0(T1b means that tumor invades submucosa) or T2-T4aN0/+ M0 (T4a means resectable tumor invading pleura, pericardium, or diaphragm) according to American Joint Committee on Cancer (AJCC)Cancer Stage 7th
- Pathological identified esophageal squamous cell cancer
- Karnofsky Performance Status(KPS)≥70
- Tolerable and agree for Intensity-Modulated Radiation Therapy(IMRT) and concurrent chemoradiotherapy
- Without severe other diseases
- Informed consent
Exclusion Criteria:
- Cervical esophagus cancer;
- Had received prior chemotherapy and thoracic radiotherapy
- Distant metastasis before treatment, including: pleural, pericardial or peritoneal cytology ,involvement of distant organs including the lungs, liver, bone, brain or non-regional lymph nodes
- Pregnant and lactating women
- Serious complications
- Other primary malignancies
- Cannot perform DW-MRI at specified time
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Pathologic response
Tidsram: after surgury
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Pathologic response will be assessed after surgery by two pathologists blinded to clinical and radiologic findings in the surgical specimen as follows : P0: no residual cancer cells P1: 1%-50% residual cancer cells; rare individual cancer cells or minute clusters of cancer cells P2: More than 50% residual cancer cells, often grossly identifiable at primary site
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after surgury
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Overall survival
Tidsram: up to 60 months
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Overall survival is defined as the time (in months) from the date of admission to the date of death from any cause or last follow-up
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up to 60 months
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Progression free survival
Tidsram: up to 60 months
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Overall survival is defined as the time (in months) from the date of admission to the date of progression
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up to 60 months
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Neoplasmer i huvud och hals
- Esofagussjukdomar
- Carcinom
- Kroppsvikt
- Esofagusneoplasmer
Andra studie-ID-nummer
- 89000--0000
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Kliniska prövningar på Esofaguskarcinom
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)AvslutadSteg IIIA Esophageal Adenocarcinom | Steg IIIB Esophageal Adenocarcinom | Steg IIIC Esophageal Adenocarcinom | Steg IIB Esophageal Adenocarcinom | Steg IB Esophageal Adenocarcinom | Steg IIA Esophageal AdenocarcinomFörenta staterna
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Memorial Sloan Kettering Cancer CenterIntegra LifeSciences CorporationAvslutadEsophageal AdenocarcinomFörenta staterna
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AvslutadAdenocarcinom i Gastro-oesofageal Junction | Steg IIIA Esophageal Adenocarcinom | Steg IIIB Esophageal Adenocarcinom | Steg IIIC Esophageal Adenocarcinom | Steg IIB Esophageal AdenocarcinomFörenta staterna
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CDx DiagnosticsAvslutadBarrett Esophagus | Esophageal Adenocarcinom | Esophageal dysplasiBelgien
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McGill UniversityAvslutadGastriskt adenokarcinom | Esophageal AdenocarcinomKanada
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Massachusetts General HospitalAvslutadGastriskt adenokarcinom | Esophageal AdenocarcinomFörenta staterna
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University of Wisconsin, MadisonIpsenRekryteringGastriskt adenokarcinom | Esophageal AdenocarcinomFörenta staterna
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McGill University Health Centre/Research Institute...RekryteringGastriskt adenokarcinom | Esophageal AdenocarcinomKanada
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AvslutadGastroesofageal Junction Adenocarcinoma | Steg IB Esophageal Adenocarcinom AJCC v7 | Steg II Esophageal Adenocarcinoma AJCC v7 | Steg IIA Esophageal Adenocarcinoma AJCC v7 | Steg IIB Esophageal Adenocarcinoma AJCC v7 | Steg IIIA Esophageal Adenocarcinom AJCC v7 | Steg IIIB esofagusadenokarcinom AJCC...Förenta staterna
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The Affiliated Hospital of the Chinese Academy...OkändEsophageal skivepitelcancerKina
Kliniska prövningar på DW-MRI
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Air Force Military Medical University, ChinaOkänd
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)Aktiv, inte rekryterandeHuvud- och halscancerFörenta staterna
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University of Michigan Rogel Cancer CenterAvslutadBröstcancerFörenta staterna
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The Hospital for Sick ChildrenAnmälan via inbjudan
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Universitaire Ziekenhuizen KU LeuvenOkändUpprepning | Livmoderhalscancer | Diffusionsviktad MRTBelgien
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)AvslutadOsteosarkom | Ewing Sarkom | Pagets sjukdomFörenta staterna
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European Organisation for Research and Treatment...Japan Clinical Oncology Group; European Society of Surgical OncologyAvslutadKolorektal cancer | Koloncancer Levermetastaser | Malign neoplasm i ändtarmen som metastaserar till levernFrankrike, Japan, Belgien, Förenta staterna, Österrike
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Fondazione IRCCS Istituto Nazionale dei Tumori,...Avslutad
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American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupOkändBröstcancer | BIRADS 3 | BIRADS 4 | BIRADS 5Förenta staterna
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American College of Radiology Imaging NetworkNational Cancer Institute (NCI)AvslutadBröstcancerFörenta staterna