NCT00003637

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy alone is more effective than radiation therapy plus chemotherapy in treating cancer of the nasopharynx. PURPOSE: This randomized phase III trial is studying how well radiation therapy and chemotherapy works compared to radiation therapy alone in treating patients with previously untreated cancer of the nasopharynx.

Trial Health

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Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for phase_3 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 19, 2013

Status Verified

January 1, 2006

First QC Date

November 1, 1999

Last Update Submit

December 18, 2013

Conditions

Head and Neck Cancer

Keywords

stage III lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynx

Outcome Measures

Primary Outcomes (4)

  • Clinical response

  • Distant metastases

  • Disease-free survival

  • Overall survival

Interventions

cisplatinDRUG
fluorouracilDRUG
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed nasopharyngeal cancer that is previously untreated WHO Type III * Stage III/IV (T3-4 Nx M0 or Tx N2-3 M0) confirmed by CT PNS * No evidence of distant metastases detected on chest x-ray, bone scan, and liver ultrasound PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * SAP and SGOT less than 2 times upper limit of normal * Bilirubin less than 1.4 mg/dL Renal: * Creatinine less than 1.6 mg/dL * Creatinine clearance greater than 50 mL/min Other: * No other malignant disease PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * See Disease Characteristics * No concurrent aminoglycoside antibiotics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre - Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

CisplatinFluorouracilRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Eu J. Chua, MD

    National Cancer Centre, Singapore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1998

Last Updated

December 19, 2013

Record last verified: 2006-01

Locations

SG(1)