Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-31 @ 7:21 PM
Study NCT ID:
NCT01605305
Status:
COMPLETED
Last Update Posted:
2012-05-24
First Post:
2012-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
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': 'C410216', 'term': 'Folfox protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-23', 'studyFirstSubmitDate': '2012-05-22', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TPP', 'timeFrame': 'from the first cycle of treatment (day one) to two month after the last cycle'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'from the first cycle of treatment (day one) to two month after the last cycle'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic esophagus.', 'detailedDescription': 'Explore whether FOLFOX6 as treatment could improve the TTP and OS of the patient with recurrent or metastatic esophagus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically proven primary thoracic esophageal squamous cell carcinoma\n2. Without chemotherapy or neo-adjuvant chemotherapy in 6 weeks ,radiotherapy has end at least 1 month,target lesion was not in an irradiated area.\n3. Presence of at least one index lesion measurable by CT scan or MRI\n4. 18\\~75 years\n5. kps ≥ 70\n6. Life expectancy of ≥ 3 months\n7. ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L\n8. Cr ≤ 1.0×UNL\n9. TB ≤ 1.25×UNL； ALT/AST ≤ 2.5×UNL，THE patient with liver metastasis ALT/AST ≤ 5.0×UNL；AKP ≤ 2.5×UNL\n10. Signed written informed consent\n\nExclusion Criteria:\n\n1. Previous exposure to oxa therapy in one year\n2. diameter of tumor abdominal ≥ 10cm, Total volumes of liver lesions ≥ 50%,lung metastasis ≥ 25% total lung\n3. chronic diarrhea,enteritis,intestine obstruction which are not under control\n4. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.\n5. peripheral neuropathy ≥ CTCAE 1\n6. Other serious disease\n7. Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.\n8. USE OTHER ANTITUMOR THERAPY\n9. Breast-feeding or pregnant women, no effective contraception if risk of conception exists'}, 'identificationModule': {'nctId': 'NCT01605305', 'briefTitle': 'Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase II Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer', 'orgStudyIdInfo': {'id': 'FOLFOX6-2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FOLFOX6', 'interventionNames': ['Drug: FOLFOX6']}], 'interventions': [{'name': 'FOLFOX6', 'type': 'DRUG', 'description': 'OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h', 'armGroupLabels': ['FOLFOX6']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'chang j h, post-doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate chief physician', 'investigatorFullName': 'Chang Jian Hua', 'investigatorAffiliation': 'Fudan University'}}}}