Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-28 @ 3:30 AM
Study NCT ID:
NCT02023593
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C480833', 'term': 'IFL protocol'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2013-12-23', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': 'Up to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From the date of first drug administration until the date of death, assessed up to 60months'}, {'measure': 'Adverse events', 'timeFrame': 'Each follow up visit, assessed up to 24 weeks', 'description': 'Safety profile will be assessed using the NCI CTCAE version 3.0'}, {'measure': 'Progression free survival', 'timeFrame': 'From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Advanced Esophageal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal carcinoma.', 'detailedDescription': 'Although there are no standard second-line treatment for metastatic esophageal carcinoma, some studies have showed that irinotecan, fluorouracil may be effective in treating patients with metastatic esophageal carcinoma after failure of first-line treatment. Since irinotecan, fluorouracil, and leucovorin work in different ways to stop the growth of tumor. Giving more than one drug may be more effective. In this phase Ⅱ trial, the investigator would like to observe the efficacy and safety of FOLFIRI(Irinotecan/5-FU/leucovorin ) as second-line treatment for metastatic esophageal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients have provided a signed Informed Consent Form\n* Karnofsky score ≥70\n* Age: 18-75 years old\n* Histologically confirmed diagnosis of advanced esophageal carcinoma\n* Patients have Received and progressed on first-line treatment, and not received CPT-11 or Fluoropyrimidine based palliative chemotherapy\n* Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria\n* Life expectancy ≥ 3 months\n* Patient has adequate bone marrow and organ function\n\n * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L\n * Platelets ≥ 75 x 109/L\n * Hemoglobin ≥ 9.0 g/dL\n* Patient has adequate liver function\n\n * AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)\n * Serum bilirubin ≤ 2 x ULN\n* Creatinine ≤ 1.5 times ULN\n* Good compliance\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Brain metastasis or only with bone metastasis.\n* Patients with severe infection or active peptic ulcer which need treatment\n* Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases\n* Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ\n* Psychiatric illness that would prevent the patient from giving informed consent\n* Patient is concurrently using other approved or investigational antineoplastic agent'}, 'identificationModule': {'nctId': 'NCT02023593', 'briefTitle': 'FOLFIRI as Second Line Chemotherapy for Metastatic Esophageal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Phase Ⅱ Study of FOLFIRI as Second-Line Chemotherapy for Metastatic Esophageal Carcinoma', 'orgStudyIdInfo': {'id': 'FOLFIRI-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FOLFIRI', 'description': 'Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.', 'interventionNames': ['Drug: FOLFIRI']}], 'interventions': [{'name': 'FOLFIRI', 'type': 'DRUG', 'otherNames': ['Irinotecan', 'Leucovorin', '5-Fluorouracil'], 'description': 'Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.', 'armGroupLabels': ['FOLFIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Li Yuhong, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhong Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD,Ph D', 'investigatorFullName': 'Yuhong Li', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}