Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-06 @ 4:33 AM
Study NCT ID:
NCT02476669
Status:
UNKNOWN
Last Update Posted:
2020-08-14
First Post:
2015-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serial Plasma EBV DNA for 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2015-06-16', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause'}], 'secondaryOutcomes': [{'measure': 'Cancer-specific survival', 'timeFrame': '3 years', 'description': 'Cancer-specific survival is calculated from the date of diagnosis of NPC to the date of death due to cancer'}, {'measure': 'Progression-free survival', 'timeFrame': '3 years', 'description': 'Progression-free survival is calculated from the date of diagnosis of NPC to the date of progression of NPC or the date of death from any cause, whichever comes earlier.'}, {'measure': 'Distant metastasis-free survival', 'timeFrame': '3 years', 'description': 'Distant metastasis-free survival is calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.'}, {'measure': 'Regional failure-free survival', 'timeFrame': '3 years', 'description': 'Regional failure-free survival is calculated from the date of diagnosis of NPC to the date of regional nodal failure or date of death from any cause, whichever comes earlier.'}, {'measure': 'Local failure-free survival', 'timeFrame': '3 years', 'description': 'Local failure-free survival is calculated from the date of diagnosis of NPC to the date of local failure or date of death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['plasma EBV DNA', 'biomarker', 'intensity-modulated radiation therapy'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '31527689', 'type': 'DERIVED', 'citation': 'Nicholls JM, Lee VH, Chan SK, Tsang KC, Choi CW, Kwong DL, Lam KO, Chan SY, Tong CC, So TH, Leung TW, Luk MY, Khong PL, Lee AW. Negative plasma Epstein-Barr virus DNA nasopharyngeal carcinoma in an endemic region and its influence on liquid biopsy screening programmes. Br J Cancer. 2019 Oct;121(8):690-698. doi: 10.1038/s41416-019-0575-6. Epub 2019 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China, Hong Kong, Taiwan, Singapore and Malaysia. It is highly associated with Epstein-Barr virus (EBV). Radiation therapy alone is indicated for early stage I to II diseases while concurrent chemoradiation is required for more advanced stage III to IVB diseases. Intensity-modulated radiation therapy (IMRT) is the standard radiation technique for NPC, in virtue of its superior target coverage and dose sparing to adjacent critical organs-at-risks.\n\nPlasma EBV DNA and other novel plasma biomarkers have been extensively investigated in NPC. Previous studies have proven their predictive and prognostic values in NPC diagnosis, surveillance and survival outcomes.\n\nWe would like to investigate the roles of plasma biomarkers including plasma EBV DNA on treatment response evaluation, survival and prognosis on NPC, in the modern era of precision radiation therapy. This will provide important information on refining on the current edition of AJCC/UICC staging classification.', 'detailedDescription': "Patients with histologically confirmed previously untreated NPC are be recruited to join tis study. The study has obtained approval from local institutional review board.\n\nAfter written informed consent, baseline investigations including blood tests for routine hematology, biochemistry and plasma EBV DNA will be taken. Only 3ml of EDTA blood will be taken for plasma EBV DNA and other potential biomarkers. They will also undergo baseline imaging investigations including positron-emission tomography with integrated computed tomography (PET-CT) and magnetic resonance imaging (MRI) of the head and neck regions. An routine nasoendoscopy and nasopharyngeal biopsies will be obtained to confirm and delineate the mucosal extent of the disease.\n\nIf confirmed non-metastatic, patients will be treated with IMRT using 7-9 radiation beams. A total dose of 70Gy in 33-35 fractions over 6.5 to 7 weeks will be given. For advanced stage III to IVB diseases, concurrent chemoradiation using cisplatin 100mg/m2 on Day 1, 22 and 43 of IMRT followed by 3 cycles of adjuvant chemotherapy with cisplatin 80mg/m2 on Day 1 and 5-FU 1000mg/m2 from Day 1 to Day 4 every 4 weeks for 3 more cycles starting 4 weeks after completion of IMRT will also be given. Some patients will also receive induction chemotherapy with either (1) cisplatin 100mg/m2 on Day 1 and 5-FU 1000mg/m2 on Day 1 to 5, or cisplatin 100mg/m2 on Day 1 and gemcitabine 1000mg/m2 on Day 1 and Day 8, administered every 3 weeks for 3 cycles before commencement of chemoradiation, at the discretion of treating oncologists if their primary tumours are close to critical organs e.g. brainstem, optic chiasm or optic nerves.\n\nAfter treatment patients will undergo nasopharyngeal biopsies, patients will undergo nasopharyngeal biopsies again at 8 weeks after completion of IMRT to confirm histological complete local remission. Blood will be taken again on the same day for plasma EBV DNA and other potential biomarkers. Additional biopsies and salvage local treatment e.g. brachytherapy, stereotactic or IMRT boost will be offered to patients who have persistent local disease at 12 weeks after completion of IMRT. If complete local remission is confirmed, patient will have regular follow up every 3 to 4 months for surveillance and survival outcomes. Regular imaging with MRI and CT scans every 3 to 4 months will also be arranged as well. Plasma EBV DNA will be measured again at 6 months and 1 year after completion of IMRT and then as clinically indicated afterwards.\n\nFor those with metastatic diseases at diagnosis, systemic chemotherapy (platinum-based chemotherapy with cisplatin and gemcitabine) will be offered. Blood taking for plasma EBV DNA and other potential biomarkers at baseline before chemotherapy commencement and then after every 3 cycles will be arranged. Plasma EBV DNA measurement and imaging examinations with CT and MRI scans will be arranged at baseline and then after 3-4 cycles of chemotherapy for tumour response evaluation. If the disease does not show progression according to RECIST 1.1, patients will receive up to 6 cycles of chemotherapy followed by consolidation IMRT to the nasopharynx and the neck with 60-70Gy in 33-35 fractions over 6-7 weeks. Additional stereotactic body radiation therapy (SBRT) will be offered to patients who have oligo-progression/oligo-metastasis (up to 3 lesions). Patients will have regular follow up every 3-4 months afterwards. Further salvage palliative chemotherapy or radiation therapy or best supportive care depending on the patients' wish and performance status will be offered to those who develop further relapse after first-line chemotherapy and/or consolidation IMRT.\n\nThe trend of baseline and serial plasma EBV DNA and other potential biomarkers will be monitored prospectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with histologically confirmed previously untreated nasopharyngeal carcinoma (NPC) will be invited to join this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed previously untreated nasopharyngeal carcinoma\n\nExclusion Criteria:\n\n* Patients who are pregnant or lactating\n* Patients who are not mentally capable of giving written informed consent\n* Patients with performance status ECOG=3 or above or patients who are expected not able to tolerate radiation therapy and/or chemotherapy\n* Patients who refuse active treatment for their nasopharyngeal carcinoma\n* Patients who cannot comply with radiation therapy and/or chemotherapy for their nasopharyngeal carcinoma'}, 'identificationModule': {'nctId': 'NCT02476669', 'briefTitle': 'Serial Plasma EBV DNA for Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Serial Plasma EBV DNA for Patients With Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'NPC-biomarkers1'}, 'secondaryIdInfos': [{'id': 'HKCTR-1271', 'type': 'REGISTRY', 'domain': 'Hong Kong Clinical Trials Register'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Victor Lee, FRCR', 'role': 'CONTACT', 'email': 'vhflee@hku.hk', 'phone': '852-2255-4352'}, {'name': 'Ka-On Lam, FRCR', 'role': 'CONTACT', 'email': 'lamkaon@hku.hk', 'phone': '852-2255-4352'}, {'name': 'Dora Kwong, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chi-Chung Tong, FRCR', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chun-Kin Sze, FRCR', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Clinical Oncology, Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Victor Lee, FRCR', 'role': 'CONTACT', 'email': 'vhflee@hku.hk', 'phone': '852-2255-4352'}, {'name': 'Ka-On Lam, FRCR', 'role': 'CONTACT', 'email': 'lamkaon@hku.hk', 'phone': '852-2255-4352'}], 'overallOfficials': [{'name': 'Victor Lee, FRCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant |Professor', 'investigatorFullName': 'Dr. Victor H.F. Lee', 'investigatorAffiliation': 'The University of Hong Kong'}}}}