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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00201396
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 25, 2015
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
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital.
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date February 25, 2015
Study Start Date  ICMJE August 2003
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
The primary endpoint is the disease-free survival. [ Time Frame: 10 years ]
follow up for 2 years after off study treatment
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
The primary endpoint is the disease-free survival.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
Secondary endpoints include overall survival and tumor response rate. [ Time Frame: 10 years ]
follow up for 2 years after off study treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Secondary endpoints include overall survival and tumor response rate.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma
Official Title  ICMJE A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)
Brief 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.
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Radiation: CCRT
    Radiation with weekly Cisplatin
  • Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin
    Induction C/T + CCRT
Study Arms  ICMJE
  • Active Comparator: A arm
    CCRT
    Intervention: Radiation: CCRT
  • Experimental: B arm
    Induction/CCRT
    Interventions:
    • Radiation: CCRT
    • Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin
Publications * Hong RL, Hsiao CF, Ting LL, Ko JY, Wang CW, Chang JTC, Lou PJ, Wang HM, Tsai MH, Lai SC, Liu TW. Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study. Ann Oncol. 2018 Sep 1;29(9):1972-1979. doi: 10.1093/annonc/mdy249.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2005)
480
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00201396
Other Study ID Numbers  ICMJE T1303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Health Research Institutes, Taiwan
Study Sponsor  ICMJE National Health Research Institutes, Taiwan
Collaborators  ICMJE
  • 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
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Veterans General Hospital.
  • Taipei Veterans General Hospital, Taiwan
Investigators  ICMJE
Principal Investigator: Ruey-Long Hong, MD, PhD Taiwan cooperative oncology group
PRS Account National Health Research Institutes, Taiwan
Verification Date May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP