Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Under 70	Other	T1303 NCT00201396

Trial Description

Summary

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.

Further Study Information

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 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

National Health Research Institute

Ruey-Long Hong, MD, PhD

Principal Investigator

Wei-lien Feng, RN,MSN		Ph: 886-2-8792-3311 Ext.17644
		Email: winnif@nhri.org.tw

Taiwan, Province of China
	Kaohsiung
	Kaohsiung Medical University
		Wei Te-Chih, B.S	Ph: 886-7-3121101 Ext.6109
			Email: hemawei@nhri.org.tw
		Shi-Long Lian, M.D.	Principal Investigator
	Taichung
	China Medical University Hospital
		Ya-Lin WU, B.S.	Ph: 886-4-22052121 Ext.5372
			Email: yalin@nhri.org.tw
		Ming-Hsui Tsai, M.D.	Principal Investigator
	Taipei
	National Taiwan University Hospital
		Ling-Fang Lin., B.S.	Ph: 886-2-2312-3456 Ext.7677
			Email: dale@nhri.org.tw
		Ruey-Long Hong, M.D, PhD	Principal Investigator
	Taoyuan
	Chang-Gung Memorial Hospital - Taoyuan
		Hsing-Hsun Chang, M.D	Ph: 886-03-3281200 Ext.2512
			Email: sissi566@nhri.org.tw
		Joseph T. Chang, M.D	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00201396
Information obtained from ClinicalTrials.gov on April 03, 2009