Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT03579004
Status:
UNKNOWN
Last Update Posted:
2018-07-06
First Post:
2018-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], '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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-04', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-07-04', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '24 months', 'description': 'Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '24 months', 'description': 'Overall survival will be calculated from the start of the treatment to the death of any reason.'}, {'measure': 'Objective response rate according to RECIST 1.1', 'timeFrame': '24 months', 'description': 'Objective response rate will be evaluated separately after chemotherapy and chemoradiotherapy.'}, {'measure': 'Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': '24 months', 'description': 'Toxicity will be assessed separately after chemotherapy, chemoradiotherapy and surgery according NCI CTC AE 4.0'}, {'measure': 'Pathological complete response rate following chemoradiotherapy', 'timeFrame': '24 months', 'description': 'Pathological complete response rate following chemoradiotherapy will be assessed in resected patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal squamous cell carcinoma', 'preoperative chemoradiotherapy', 'preoperative chemotherapy'], 'conditions': ['Esophageal Neoplasms', 'Squamous Cell Carcinoma', 'Concurrent Chemoradiotherapy']}, 'descriptionModule': {'briefSummary': 'This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma', 'detailedDescription': 'This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma.\n\nPatients with resectable esophageal squamous cell carcinoma receive 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). Patients who do not progress with distant metastases start preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gy for 4 weeks).\n\n4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy irrespectively of objective response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18-75\n2. Histologically or cytologically confirmed resectable squamous-cell Tumor (T)1-2 node (N)+, T3N0-3 esophageal cancer. Inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed\n3. No prior antineoplastic treatment\n4. Eastern Cooperative Oncology Group (ECOG) status 0-2\n5. Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy\n\n * absolute neutrophil count ≥ 1,500 х109/l\n * thrombocytes ≥ 100 х 109/l\n * hemoglobin ≥ 90 mg/l\n * creatinine \\< 115 µmol/л or creatinine clearance ≥ 55 ml/min\n * alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2.5 x upper limit of normal (ULN)\n * alkaline phosphatase (ALP) \\> 5 x ULN\n * bilirubin \\> 1,5 х ULN\n6. Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment\n7. Patients must follow appropriate contraception rules during whole treatment period\n8. Decrease of body weight must not be more than 20% in last 6 months\n\nExclusion Criteria:\n\n1. Presence of distant metastases except for metastatic supraclavicular lymphnodes;\n2. Bulky (\\>3 cm) regional lymphnodes metastases;\n3. Cervical esophageal cancer;\n4. Presence of tumor fistula;\n5. Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer;\n6. Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;'}, 'identificationModule': {'nctId': 'NCT03579004', 'briefTitle': 'Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Russian Academy of Medical Sciences'}, 'officialTitle': 'Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study', 'orgStudyIdInfo': {'id': '2017-038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trimodality approach', 'description': '2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks).\n\n4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Cisplatin', 'Drug: Fluorouracil', 'Radiation: chemoradiotherapy', 'Procedure: Ivor Lewis esophagogastrectomy']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['chemotherapy'], 'description': 'Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy', 'armGroupLabels': ['Trimodality approach']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['chemotherapy'], 'description': 'Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy', 'armGroupLabels': ['Trimodality approach']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'otherNames': ['chemotherapy'], 'description': 'Fluorouracil is used in two cycles of neoadjuvant chemotherapy', 'armGroupLabels': ['Trimodality approach']}, {'name': 'chemoradiotherapy', 'type': 'RADIATION', 'otherNames': ['chemoradiation'], 'description': 'Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.', 'armGroupLabels': ['Trimodality approach']}, {'name': 'Ivor Lewis esophagogastrectomy', 'type': 'PROCEDURE', 'description': 'Open Ivor Lewis esophagogastrectomy', 'armGroupLabels': ['Trimodality approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115478', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexey Tryakin, MD, PhD', 'role': 'CONTACT', 'email': 'atryakin@mail.ru', 'phone': '4993249259', 'phoneExt': '+7'}], 'facility': 'Alexey Tryakin', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115478', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexey Tryakin, PhD', 'role': 'CONTACT', 'email': 'atryakin@mail.ru', 'phone': '+74993249259'}, {'name': 'Ilya Pokataev', 'role': 'CONTACT', 'email': 'pokia@mail.ru', 'phone': '+74993241219'}, {'name': 'Alexey Tryakin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Russian Cancer Research Center named after N.N.Blokhin RAMS', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Alexey Tryakin, MD, PhD', 'role': 'CONTACT', 'email': 'atryakin@mail.ru', 'phone': '4993249259', 'phoneExt': '+7'}, {'name': 'Ilya Pokataev, MD, PhD', 'role': 'CONTACT', 'email': 'pokia@mail.ru', 'phone': '4993241219', 'phoneExt': '+7'}], 'overallOfficials': [{'name': 'Alexey Tryakin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'N.N.Blokhin Russian Cancer Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mona Frolova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Staff Member', 'investigatorFullName': 'Mona Frolova', 'investigatorAffiliation': 'Russian Academy of Medical Sciences'}}}}