NCT00201396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 25, 2015

Status Verified

May 1, 2006

Enrollment Period

6 years

First QC Date

September 13, 2005

Last Update Submit

February 23, 2015

Conditions

Nasopharyngeal Carcinoma

Keywords

A Multicenter Phase III TrialInduction ChemotherapyConcurrent ChemoradiotherapyStage IV Nasopharyngeal Carcinoma (NPC)randomizationdisease-free survival

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the disease-free survival.

    follow up for 2 years after off study treatment

    10 years

Secondary Outcomes (1)

  • Secondary endpoints include overall survival and tumor response rate.

    10 years

Study Arms (2)

A arm

ACTIVE COMPARATOR

CCRT

Radiation: CCRT

B arm

EXPERIMENTAL

Induction/CCRT

Radiation: CCRTDrug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin

Interventions

CCRTRADIATION

Radiation with weekly Cisplatin

A armB arm
Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,LeucovorinDRUG

Induction C/T + CCRT

B arm

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kaohsiung Medical University Hospital

Kaohsiung City, 80708, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 115, Taiwan

Location

Chang-Gung Memorial Hospital(Lin-Kou),

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 30016391DERIVED

Related Links

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ruey-Long Hong, MD, PhD

    Taiwan cooperative oncology group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

August 1, 2003

Primary Completion

August 1, 2009

Study Completion

December 1, 2011

Last Updated

February 25, 2015

Record last verified: 2006-05

Locations

TW(4)