Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00817258
Status:
UNKNOWN
Last Update Posted:
2009-01-06
First Post:
2009-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Concurrent Chemotherapy and Radiotherapy for Stage II 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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-05', 'studyFirstSubmitDate': '2009-01-02', 'studyFirstSubmitQcDate': '2009-01-05', 'lastUpdatePostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '3 and 5 years'}], 'secondaryOutcomes': [{'measure': 'disease-free survival, and distant metastases free survival', 'timeFrame': '3 and 5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase 2 Clinical Trial', 'NPC', 'radiation therapy', 'chemotherapy'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the overall survival in patients with stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy.\n\nSecondary objectives of the study are to evaluate the disease free survival, and distant metastases free survival of patients with stage II NPC treated with this regimen', 'detailedDescription': 'Radiotherapy alone is the standard treatment for early stage NPC. In retrospective study of early stage NPC patients treated with radiotherapy alone. Patients who had Stage II disease had a worse outcome compared with patients with stage I disease. Chemotherapy, delivered concurrently with radiation therapy, has been adopted as standard treatment for locally advanced NPC. However, concurrent chemoradiation for stage II NPC patients has never been prospectively studied. In the present trial, we hope to assess the value of concurrent chemotherapy and radiotherapy in patients with stage II (T1-2N1) NPC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.\n* Stage II disease (T1-2; N1; M0)\n* KPS \\>70\n* Age between 18-70\n* Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \\> 2000 cells/mm3, platelet count of \\> 100,000 cells/mm3 (pre treatment without intervention). Bilirubin \\< 1.5 mg/dl, AST or ALT\\<2 x upper normal, serum creatinine\\<1.5mg/dl, creatinine clearance \\>50ml/min.\n* No prior radiation treatment to the head and neck or any prior chemotherapy\n* Patients with no prior malignancy (not include basal cell carcinoma of skin)\n\nExclusion Criteria:\n\n* Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.\n* Prior radiotherapy to the head and neck region for any reason.\n* Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.\n* Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT00817258', 'briefTitle': 'Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'NPC-0701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.', 'interventionNames': ['Drug: cisplatin', 'Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'description': 'Cisplatin 40mg/m2,weekly', 'armGroupLabels': ['1']}, {'name': '3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)', 'type': 'RADIATION', 'description': '3D-CRT or IMRT', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Yuan', 'role': 'CONTACT', 'email': 'skelly_sh@hotmail.com', 'phone': '8621-64175590', 'phoneExt': '6511'}], 'facility': 'Department of Radiation Oncology, Cancer Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lin Kong, MD', 'role': 'CONTACT', 'email': 'konglinj@gmail.com', 'phone': '8621-64175590', 'phoneExt': '3900'}], 'overallOfficials': [{'name': 'Lin Kong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Cancer Hospital, Fudan University'}, {'name': 'Chaosu Hu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Cancer Hospital, Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Radiation Oncology,Cancer Hospital, Fudan University, Shanghai, China', 'oldOrganization': 'Cancer Hospital, Fudan University, Shanghai, China'}}}}