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

Brief Title

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

Official Title

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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

The primary endpoint is the disease-free survival.

Secondary Outcome

 Secondary endpoints include overall survival and tumor response rate.

Condition

Nasopharyngeal Carcinoma

Intervention

CCRT

Study Arms / Comparison Groups

 A arm

Description:  CCRT

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Radiation

Estimated Enrollment

Start Date

August 2003

Completion Date

December 2011

Primary Completion Date

August 2009

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.

Gender

All

Ages

N/A - 70 Years

Accepts Healthy Volunteers

No

Contacts

Ruey-Long Hong, MD, PhD, ,

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT00201396

Organization ID

T1303

Responsible Party

Sponsor

Study Sponsor

National Health Research Institutes, Taiwan

Collaborators

 National Taiwan University Hospital

Study Sponsor

Ruey-Long Hong, MD, PhD, Principal Investigator, Taiwan cooperative oncology group

Verification Date

May 2006