Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-29 @ 11:59 PM
Study NCT ID:
NCT02527057
Status:
UNKNOWN
Last Update Posted:
2016-08-17
First Post:
2015-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diffusion-weighted Magnetic Resonance Imaging (DW-MRI )for Early Response Assessment in Patients With Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2015-08-16', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic response', 'timeFrame': 'after surgury', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to 60 months', 'description': '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'}, {'measure': 'Progression free survival', 'timeFrame': 'up to 60 months', 'description': 'Overall survival is defined as the time (in months) from the date of admission to the date of progression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diffusion-weighted magnetic resonance imaging', 'Preoperative concurrent chemoradiation', 'Response'], 'conditions': ['Esophageal Carcinoma']}, 'descriptionModule': {'briefSummary': '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.\n\nInvestigators 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants will have histologically confirmed esophageal squamous cell carcinoma with no contraindications for receiving neoadjvuant chemoradiation followed by surgery. All participants will be required to give informed consent to participate in the protocol, which has been approved by the review boards of the participating institutions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Pathological identified esophageal squamous cell cancer\n* Karnofsky Performance Status（KPS）≥70\n* Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy\n* Without severe other diseases\n* Informed consent\n\nExclusion Criteria:\n\n* Cervical esophagus cancer;\n* Had received prior chemotherapy and thoracic radiotherapy\n* 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\n* Pregnant and lactating women\n* Serious complications\n* Other primary malignancies\n* Cannot perform DW-MRI at specified time'}, 'identificationModule': {'nctId': 'NCT02527057', 'briefTitle': 'Diffusion-weighted Magnetic Resonance Imaging (DW-MRI )for Early Response Assessment in Patients With Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '89000--0000'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DW-MRI', 'type': 'DEVICE', 'description': 'Participants will perform four DW-MRI scanning as follows,before chemoradiation , at 2 weeks , 4 weeks after the start of radiotherapy and before the surgery.If participants can not receive surgery,the last scanning time will replaced at the end of radiotherapy.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'shengqi wu, M.D.', 'role': 'CONTACT', 'email': 'wushengqi@hnszlyy.com', 'phone': '13807316075'}], 'facility': 'Hunan province tumor pospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, {'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief of thoracic radiation oncology department', 'investigatorFullName': 'Hui Wang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}