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Sponsors and Collaborators: |
National Health Research Institutes, Taiwan National Taiwan University Hospital Tri-Service General Hospital Chang Gung Memorial Hospital China Medical University Hospital Chung Shan Medical University Changhua Christian Hospital Chi-Mei Foundation Hospital . |
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Information provided by: | National Health Research Institutes, Taiwan |
ClinicalTrials.gov Identifier: | NCT00201396 |
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.
Condition | Intervention | Phase |
---|---|---|
Nasopharyngeal Carcinoma |
Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC) |
Estimated Enrollment: | 480 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | December 2013 |
Rationale of induction chemotherapy:
Distant metastasis is the major cause of treatment failure and deaths in patients with loco-regionally advanced NPC.
Concurrent chemoradiotherapy may prolong survivals for patients with advanced NPC, but it is still flawed by high incidence of distant metastasis.
Induction chemotherapy with MEPFL has been shown to reduce the incidence of distant metastasis in a Phase II study.
Induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of patients with advanced NPC.
Objectives:
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.
Study design:
This is a randomized, multi-center Phase III study. Patients will be randomized to CCRT with or without the MEPFL induction chemotherapy.
Type and number of patients:
Patients with stage IVA (T4) and/or IVB (N3) but without distant metastasis will be enrolled. A total of up to 480 patients will be randomized to detect an improvement of median overall survival from 5.8 to 8.7 years, with an a=0.05 and power of 0.8 using a two-sided logrank test with one interim analysis.
Treatment schedule:
Induction chemotherapy and CCRT:
Arm A: Weekly cisplatin concurrently with radiotherapy Arm B: Induction MEPFL three cycles followed with weekly cisplatin concurrently with radiotherapy.
Study endpoints:
The primary endpoint is the disease-free survival that will be calculated as the duration between the date of randomization and the date of recurrence of NPC at any site including persistent disease after +induction chemotherapy/CCRT, or death from any cause (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).( revised 8/27/2004)
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wei-lien Feng, RN,MSN | 886-2-8792-3311 ext 17644 | winnif@nhri.org.tw |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 115 | |
Contact: Ling-Fang Lin., B.S. 886-2-2312-3456 ext 7677 dale@nhri.org.tw | |
Principal Investigator: Ruey-Long Hong, M.D, PhD | |
Chang-Gung Memorial Hospital(Lin-Kou), | Recruiting |
Taoyuan, Taiwan, 333 | |
Contact: Hsing-Hsun Chang, M.D 886-03-3281200 ext 2512 sissi566@nhri.org.tw | |
Principal Investigator: Joseph T. Chang, M.D | |
China Medical University Hospital | Recruiting |
Taichung, Taiwan, 40447 | |
Contact: Ya-Lin WU, B.S. 886-4-22052121 ext 5372 yalin@nhri.org.tw | |
Principal Investigator: Ming-Hsui Tsai, M.D. | |
Kaohsiung Medical University Hospital | Recruiting |
Kaohsiung, Taiwan, 80708 | |
Contact: Wei Te-Chih, B.S 886-7-3121101 ext 6109 hemawei@nhri.org.tw | |
Principal Investigator: Shi-Long Lian, M.D. |
Principal Investigator: | Ruey-Long Hong, MD, PhD | Taiwan cooperative oncology group |
Study ID Numbers: | T1303 |
Study First Received: | September 13, 2005 |
Last Updated: | May 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00201396 |
Health Authority: | Taiwan: Department of Health |
A Multicenter Phase III Trial Induction Chemotherapy Concurrent Chemoradiotherapy |
Stage IV Nasopharyngeal Carcinoma (NPC) randomization disease-free survival |
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Pharyngeal Neoplasms Leucovorin Mitomycins Pharyngeal Diseases Epirubicin Nasopharyngeal Neoplasms |
Carcinoma Nasopharyngeal carcinoma Cisplatin Head and Neck Neoplasms Fluorouracil Mitomycin Stomatognathic Diseases Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Nasopharyngeal Diseases Alkylating Agents Nucleic Acid Synthesis Inhibitors |