A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by National Health Research Institutes, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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 Medical Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00201396
First received: September 13, 2005
Last updated: April 2, 2009
Last verified: May 2006
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • The primary endpoint is the disease-free survival.

Secondary Outcome Measures:
  • Secondary endpoints include overall survival and tumor response rate.

Estimated Enrollment: 480
Study Start Date: August 2003
Estimated Study Completion Date: December 2013
Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proved nasopharyngeal carcinoma.
  • T4NxM0 or TxN3M0 disease by UICC/AJCC 1997 staging system. (30)
  • Eastern Cooperative Oncology Group performance status < 2.
  • A leukocyte count ≥3750/mL, Hb ≥ 10 g/dL, and a platelet count ≥100,000/mL.
  • A serum bilirubin level < 1.5 mg/dL, serum creatinine level < 1.6 mg/dL or creatinine clearance > 60 mL/min.
  • Age less than 70 years old
  • An informed consent signed.

Exclusion Criteria:

  • Evidence of metastatic disease.
  • Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.
  • Presence of uncontrolled hypertension, poorly controlled heart failure.
  • Presence of active infection.
  • Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.
  • Women who test positive for pregnancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201396

Contacts
Contact: Wei-lien Feng, RN,MSN 886-2-8792-3311 ext 17644 winnif@nhri.org.tw

Locations
Taiwan
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.         
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.         
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         
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 Medical Hospital
Investigators
Principal Investigator: Ruey-Long Hong, MD, PhD Taiwan cooperative oncology group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00201396     History of Changes
Other Study ID Numbers: T1303
Study First Received: September 13, 2005
Last Updated: April 2, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
A Multicenter Phase III Trial
Induction Chemotherapy
Concurrent Chemoradiotherapy
Stage IV Nasopharyngeal Carcinoma (NPC)
randomization
disease-free survival

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mitomycins
Mitomycin
Epirubicin
Cisplatin
Fluorouracil
Leucovorin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Radiation-Sensitizing Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014