Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-02-04 @ 4:06 PM
Study NCT ID:
NCT02603159
Status:
UNKNOWN
Last Update Posted:
2015-11-11
First Post:
2015-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-09', 'studyFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2015-11-09', 'lastUpdatePostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival, OS', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '2 years'}, {'measure': 'overall remission rate, ORR', 'timeFrame': '16 weeks'}, {'measure': 'serious adverse event', 'timeFrame': '16 weeks'}, {'measure': 'quality of life, Qol', 'timeFrame': '16 weeks'}, {'measure': 'pathologic complete response rate', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chemoradiotherapy', 'Esophageal Squamous Cancer', 'Capecitabine'], 'conditions': ['Stage III Esophageal Squamous Cell Carcinoma', 'Stage II Esophageal Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '20888705', 'type': 'BACKGROUND', 'citation': 'Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer.But in China because of its toxic reaction, most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the chemotherapy of esophageal cancer.\n\nThe purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.', 'detailedDescription': 'We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 45-75years old\n* Histologically proven squamous cell carcinoma of the esophagus\n* the tumor was in T2-4N0-2M0\n* The patients have not received the surgery or chemo-radiotherapy.\n* Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,\n* ALT、AST≤2.5\\*N,Cr≤1.5\\*N.\n* performance status score 0-2\n\nExclusion Criteria:\n\n* pregnant, lactating women\n* Oxaliplatin or fluorouracil Allergy or metabolic disorders\n* Radiotherapy contraindications\n* History of organ transplantation\n* Brain metastasis\n* The peripheral nervous system disorders\n* Severe infection\n* Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding\n* Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.\n* Other malignant tumor in recent 5 years.'}, 'identificationModule': {'nctId': 'NCT02603159', 'acronym': 'DCECRT', 'briefTitle': 'Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Henan University of Science and Technology'}, 'orgStudyIdInfo': {'id': 'Capecitabine and esophageal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capecitabine-5 weeks-radiotherapy', 'description': 'Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.', 'interventionNames': ['Drug: Capecitabine(Aibin)', 'Radiation: radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capecitabine-10 weeks-radiotherapy', 'description': 'Capecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.', 'interventionNames': ['Drug: Capecitabine(Aibin)', 'Radiation: radiotherapy']}], 'interventions': [{'name': 'Capecitabine(Aibin)', 'type': 'DRUG', 'otherNames': ['Aibin'], 'description': 'Capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total', 'armGroupLabels': ['Capecitabine-10 weeks-radiotherapy', 'Capecitabine-5 weeks-radiotherapy']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'otherNames': ['radiation therapy'], 'description': 'Concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity', 'armGroupLabels': ['Capecitabine-10 weeks-radiotherapy', 'Capecitabine-5 weeks-radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471003', 'city': 'Luoyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'shegan gao, doctor', 'role': 'CONTACT', 'email': 'gsg112258@163.com', 'phone': '0379 64811906'}, {'name': 'tanyou shan, master', 'role': 'CONTACT', 'email': 'shantanyou@163.com', 'phone': '0379 64815350'}], 'facility': 'The First Affiliated Hospital of Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}], 'centralContacts': [{'name': 'Shegan Gao, Doctor', 'role': 'CONTACT', 'email': 'gsg112258@163.com', 'phone': '18638859977'}, {'name': 'Tanyou Shan, Master', 'role': 'CONTACT', 'email': 'shantanyou@163.com', 'phone': '18537976669'}], 'overallOfficials': [{'name': 'Shegan Gao, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Tanyou Shan, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Xiaoshan Feng, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Jiachun Sun, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Xinshuai Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Guoqiang Kong, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Xiaozhi Yuan, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Ruinuo Jia, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Dan Zhuo, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Jing Ren, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Ruina Yang, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Yali Zhang, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Yongxuan Liu, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Wei Wang, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Dan Wang, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Weijiao Yin, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}, {'name': 'Shiyuan Song, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Henan University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Henan University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}