Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-27 @ 3:50 AM
Study NCT ID:
NCT01403259
Status:
TERMINATED
Last Update Posted:
2014-08-20
First Post:
2011-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SOX as Salvage Treatment in Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'poor accrual of eligible patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-19', 'studyFirstSubmitDate': '2011-07-26', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median progression-free survival', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '6 weeks'}, {'measure': 'Median overall survival', 'timeFrame': '1.5 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal carcinoma', 'S-1', 'Oxaliplatin'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal carcinoma.', 'detailedDescription': 'The treatment option in patients with platinum-resistant relapsed or metastatic nasopharyngeal carcinoma is limited. Previous studies showed that both S-1 and oxaliplatin were effective in head and neck cancer. Moreover, SOX (S-1 plus oxaliplatin) was proved to be tolerable in advanced stage gastric cancer. Therefore, we aim to evaluate this regimen in salvage setting of nasopharyngeal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range: 18-75 years old\n* Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma\n* Prior exposure of at least one line of platinum-containing regimen\n* ECOG performance status 0-1\n* Life expectancy of more than 3 months\n* Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L\n* Liver function: total bilirubin, ALT and AST \\<1.5×UNL\n* Renal function: Cr\\<1.5×UNL, CCR≧50ml/min\n* Without \\> 1 grade of neuropathy\n\nExclusion Criteria:\n\n* With curable treatment option\n* With CNS involvement\n* Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy\n* Treated with \\> 2 lines of palliative chemotherapy\n* With prior exposure of S-1 or oxaliplatin\n* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix\n* Significant active infection\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01403259', 'briefTitle': 'SOX as Salvage Treatment in Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'HNTG 11-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-1 plus oxaliplatin', 'description': 'S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks for 6 cycles', 'interventionNames': ['Drug: S-1 plus oxaliplatin']}], 'interventions': [{'name': 'S-1 plus oxaliplatin', 'type': 'DRUG', 'otherNames': ['S-1', 'Oxaliplatin'], 'description': 'S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks', 'armGroupLabels': ['S-1 plus oxaliplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Ye Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ye Guo', 'investigatorAffiliation': 'Fudan University'}}}}