NCT03175939

Brief Summary

This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_2

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

April 1, 1998

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2008

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

10.8 years

First QC Date

May 31, 2017

Last Update Submit

June 2, 2017

Conditions

Nasopharyngeal Cancer

Keywords

adjuvant chemotherapyNPC

Outcome Measures

Primary Outcomes (1)

  • Distant-metastasis-free survival

    percentage of patients who survived and has no distant metastasis

    5 years

Secondary Outcomes (2)

  • overall survival

    5 years

  • disease-free survival

    5 years

Study Arms (1)

CCRT alone

EXPERIMENTAL

External beam radiotherapy \> 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy

Radiation: RadiotherapyDrug: CisplatinDrug: 5-FU

Interventions

RadiotherapyRADIATION

External beam radiotherapy with curative intent, at least 66 Gy

CCRT alone
CisplatinDRUG

cisplatin IV injection over 3 hours

Also known as: CDDP
CCRT alone
5-FUDRUG

5-FU IV 24 hours continuous infusion

Also known as: 5-fluorouracil
CCRT alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) biopsy-proven carcinoma of the nasopharynx,
  • (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
  • (3) normal renal function (Cr \< 1.6 mg/dl),

You may not qualify if:

  • open-neck lymph node biopsy
  • previous chemotherapy or radiotherapy to the head and neck region
  • distant metastasis or other malignant diseases except skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

RadiotherapyCisplatinFluorouracil

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Skye Hung-Chun Cheng, M.D.

    Koo Foundation Sun Yat-Sen Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician, M.D.

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 5, 2017

Study Start

April 1, 1998

Primary Completion

December 31, 2008

Study Completion

December 31, 2014

Last Updated

June 5, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share