NCT00201344

Brief Summary

  • To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of the study includes : overall survival, relapse free survival, distant metastasis and local-regional control rates.
  • To evaluate the toxicities of the two treatment methods.

Trial Health

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Trial Health Score

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

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 1994

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1994

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2000

Completed
5.7 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
Last Updated

March 26, 2010

Status Verified

June 1, 2009

First QC Date

September 13, 2005

Last Update Submit

March 25, 2010

Conditions

Nasopharyngeal Carcinoma

Keywords

RadiotherapyAdjuvant chemotherapyChemtherapyNasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • overall survival, relapse free survival,distant metastasis and local-regional control rates.

Secondary Outcomes (1)

  • toxicities of the two treatment methods.

Interventions

Cisplatin,5-FU,LeucovorinDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment.
  • Original stage must be stage IV disease (M0)
  • Patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy.
  • Performance status scale ECOG grade 0，1.
  • Creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, WBC ≧ 3,000/mm3 and PLT ≧ 100,000/mm3,or Creatinine Clearance \> 45ml/min if Creatinine \> 1.5mg/dl.
  • Patients must be younger than 70 year-old.
  • Patients must give signed informed consent.

You may not qualify if:

  • Patients had progressive disease after radiotherapy
  • Patients had evidence of distant metastasis.
  • Patients had completed radiotherapy for more than 7 weeks.
  • The presence of life-threatening illness
  • History of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of NPC cancer.
  • Previous chemotherapy.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans General Hospital-Taipei

Taipei, 112, Taiwan

Location

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

  • Kwan-Hwa Chi, MD,

    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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

November 1, 1994

Study Completion

January 1, 2000

Last Updated

March 26, 2010

Record last verified: 2009-06

Locations

TW(1)