Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-19 @ 1:54 AM
Study NCT ID:
NCT00577057
Status:
UNKNOWN
Last Update Posted:
2013-08-22
First Post:
2007-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'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': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 798}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-21', 'studyFirstSubmitDate': '2007-12-18', 'studyFirstSubmitQcDate': '2007-12-18', 'lastUpdatePostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '5-year'}, {'measure': 'Overall Survival', 'timeFrame': '5-year'}], 'secondaryOutcomes': [{'measure': 'Overall / Locoregional / Distant Failure Free Rate', 'timeFrame': '5-year'}, {'measure': 'Chemotherapy and RT toxicity', 'timeFrame': 'within 90 day from commencement of RT'}, {'measure': 'Late Toxicity', 'timeFrame': '5-year'}]}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma', 'Stage III - IVB'], 'conditions': ['Nasopharyngeal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The objectives of this clinical study are threefold:\n\n1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.\n2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or PX, respectively) in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.\n3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven nasopharyngeal carcinoma\n* Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition)\n* Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax)\n* Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated.\n* Liver scan if SGOT exceeds the institutional upper limit of normal\n* Adequate marrow: WBC \\> 4 and platelet \\> 100\n* Adequate renal function: creatinine clearance \\> 60 ml/min.\n* Satisfactory performance status: \\> 2 by ECOG System.\n\nExclusion Criteria:\n\n* WHO Type I squamous cell carcinoma or adenocarcinoma\n* Age \\> 70\n* Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique)\n* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for five years.\n* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).\n* History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).\n* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.'}, 'identificationModule': {'nctId': 'NCT00577057', 'briefTitle': 'Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Authority, Hong Kong'}, 'officialTitle': 'Randomized Trial to Evaluate the Therapeutic Gain by Changing the Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and the Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'HKEC-2006-120'}, 'secondaryIdInfos': [{'id': 'HARECCTR0500062'}, {'id': 'NPC-0501'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Conventional Radiotherapy', 'type': 'PROCEDURE'}, {'name': 'Accelerated Radiotherapy', 'type': 'PROCEDURE'}, {'name': 'Cisplatin', 'type': 'DRUG'}, {'name': '5-fluorouracil', 'type': 'DRUG'}, {'name': 'Capecitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Pamela Youde Nethersole Eastern Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'contacts': [{'name': 'Ashley Cheng, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'contacts': [{'name': 'Roger Ngan, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'contacts': [{'name': 'Dora Kwong, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'contacts': [{'name': 'Stewart Y Tung, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tuen Mun Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Anne WM Lee, Cos', 'role': 'CONTACT', 'email': 'awmlee@ha.org.hk', 'phone': '(852) 2595 4173'}], 'overallOfficials': [{'name': 'Anne WM Lee, Cos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Oncology, Pamela Youde Nethersole Eastern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hong Kong Nasopharyngeal Cancer Study Group Limited', 'class': 'OTHER'}]}}}