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Sponsors and Collaborators: |
Chinese University of Hong Kong Hong Kong Nasopharyngeal Cancer Study Group Limited |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00370890 |
The purpose of this trial is to study the benefit of adjuvant chemotherapy using gemcitabine and cisplatin in high risk NPC patients with residual EBV DNA following primary radiotherapy with or without concurrent cisplatin.
Condition | Intervention | Phase |
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Nasopharyngeal Cancer |
Drug: Adjuvant chemotherapy (gemcitabine and cisplatin) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | A Multi-center Prospective Randomized Phase III Trial to Determine the Benefit of Adjuvant Chemotherapy Using Gemcitabine and Cisplatin in Nasopharyngeal Carcinoma Patients With Residual EBV DNA Following Primary Radiotherapy With or Without Concurrent Cisplatin |
Estimated Enrollment: | 150 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Adjuvant chemotherapy and then clinical follow-up and surveillance
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Drug: Adjuvant chemotherapy (gemcitabine and cisplatin)
Gemcitabine 1000 mg/m2 in 250 ml NS over 30 mins IV on Day 1 and 8 Cisplatin 40 mg/m2 in 1L NS over 2 h IV on Day 1 and 8 Cycle repeated every 3 weeks for total of 6 cycles
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B: No Intervention
Clinical follow-up and surveillance only
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate organ and marrow function as defined below:
leukocytes >3,000/L; absolute neutrophil count >1,500/L; platelets >100,000/L; total bilirubin <1.5 X institutional upper limit of normal; AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal; Creatinine clearance > 50 ml/min
Exclusion Criteria:
Contact: Anthony TC Chan, MD, FRCP | (852) 2632 2119 | anthonytcchan@cuhk.edu.hk |
Contact: Rosalie Ho, RN | (852) 2632 1135 | rosalie@clo.cuhk.edu.hk |
Hong Kong | |
Department of Clinical Oncology, Prince of Wales Hospital | Recruiting |
Hong Kong, Hong Kong | |
Principal Investigator: Anthony TC Chan, MD, FRCP | |
Department of Clinical Oncology, Queen Elizabeth Hospital | Recruiting |
Hong Kong, Hong Kong | |
Principal Investigator: Roger KC Ngan, FRCR | |
Department of Clinical Oncology, Tuen Mun Hospital | Recruiting |
Hong Kong, Hong Kong | |
Principal Investigator: Stewart Y Tung, FRCR | |
Department of Clinical Oncology, Queen Mary Hospital | Recruiting |
Hong Kong, Hong Kong | |
Principal Investigator: Daniel TT Chua, FRCR | |
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital | Recruiting |
Hong Kong, Hong Kong | |
Principal Investigator: T K Yau, FRCR | |
Department of Oncology, Princess Margaret Hospital | Recruiting |
Hong Kong, Hong Kong | |
Principal Investigator: Ashley C Cheng, FRCR |
Principal Investigator: | Anthony TC Chan, MD, FRCP | Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong |
Principal Investigator: | Roger KC Ngan, FRCR | Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong |
Responsible Party: | Trial Coordinator, Comprehensive Cancer Trials Unit ( Rosalie Ho ) |
Study ID Numbers: | HKNPCSG 0502 |
Study First Received: | August 30, 2006 |
Last Updated: | August 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00370890 History of Changes |
Health Authority: | Hong Kong: Department of Health |
nasopharyngeal cancer adjuvant chemotherapy EBV DNA PET CT scan |
Antimetabolites Anti-Infective Agents Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Nasopharyngeal Carcinoma Immunologic Factors Adjuvants, Immunologic Pharyngeal Neoplasms Immunosuppressive Agents Antiviral Agents |
Pharyngeal Diseases Nasopharyngeal Neoplasms Carcinoma Virus Diseases Radiation-Sensitizing Agents Cisplatin Head and Neck Neoplasms Stomatognathic Diseases Gemcitabine |
Antimetabolites Anti-Infective Agents Otorhinolaryngologic Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Pharyngeal Neoplasms Nasopharyngeal Neoplasms Neoplasms by Site Cisplatin Therapeutic Uses |
Nasopharyngeal Diseases Gemcitabine Otorhinolaryngologic Diseases Adjuvants, Immunologic Enzyme Inhibitors Immunosuppressive Agents Pharyngeal Diseases Antiviral Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Head and Neck Neoplasms Stomatognathic Diseases |