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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00201396
First received: September 13, 2005
Last updated: February 23, 2015
Last verified: May 2006

September 13, 2005
February 23, 2015
August 2003
August 2009   (final data collection date for primary outcome measure)
The primary endpoint is the disease-free survival. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
follow up for 2 years after off study treatment
The primary endpoint is the disease-free survival.
Complete list of historical versions of study NCT00201396 on ClinicalTrials.gov Archive Site
Secondary endpoints include overall survival and tumor response rate. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
follow up for 2 years after off study treatment
Secondary endpoints include overall survival and tumor response rate.
Not Provided
Not Provided
 
A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma
A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)
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.

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)

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasopharyngeal Carcinoma
  • Radiation: CCRT
    Radiation with weekly Cisplatin
  • Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin
    Induction C/T + CCRT
  • Active Comparator: A arm
    CCRT
    Intervention: Radiation: CCRT
  • Experimental: B arm
    Induction/CCRT
    Interventions:
    • Radiation: CCRT
    • Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
December 2011
August 2009   (final data collection date for primary outcome measure)

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.
Both
up to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00201396
T1303
Not Provided
Not Provided
Not Provided
National Health Research Institutes, Taiwan
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
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Veterans General Hospital.
  • Taipei Veterans General Hospital, Taiwan
Principal Investigator: Ruey-Long Hong, MD, PhD Taiwan cooperative oncology group
National Health Research Institutes, Taiwan
May 2006

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