NCT02604472

Brief Summary

To investigate whether the additional induction chemotherapy (IC) to concurrent chemoradiotherapy (CCRT) was able to improve overall survival (OS) and disease-free survival (DFS), and to clarify if stage-specified chemoradiotherapy regimens benefit the most for locoregionally advanced NPC.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12,206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

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

January 1, 1998

Completed
15.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

15.4 years

First QC Date

November 11, 2015

Last Update Submit

November 12, 2015

Conditions

Keywords

Nasopharyngeal carcinomainduction chemotherapyconcurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    up to 10 years

Secondary Outcomes (1)

  • disease-free survival

    up to 10 years

Study Arms (2)

CCRT group

Locoregionally advanced nasopharyngeal carcinoma patients received concurrent chemoradiotherapy

Other: CCRT

IC+CCRT group

Locoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and concurrent chemoradiotherapy

Other: IC+CCRT

Interventions

CCRTOTHER

Locoregionally advanced nasopharyngeal carcinoma patients received platinum-based/non-platinum based concurrent chemoradiotherapy.

CCRT group
IC+CCRTOTHER

Locoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and platinum-based/non-platinum based concurrent chemoradiotherapy.

IC+CCRT group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013

You may qualify if:

  • firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013;
  • with complete medical records;
  • received radical RT.

You may not qualify if:

  • distant metastasis patients at first diagnosis,
  • recurrent patients,
  • not finishing radiotherapy, missing medical data, death during RT, stage I or II disease,received treatment previously, or without concurrent chemoradiotherapy were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Xia WX, Liang H, Lv X, Wang L, Ye YF, Ke LR, Xu LH, Guo X, Xiang YQ. Stage-specific concurrent chemoradiotherapy with or without induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma: a retrospective, population-based study. Cancer Manag Res. 2019 Nov 20;11:9813-9827. doi: 10.2147/CMAR.S179139. eCollection 2019.

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

  • Xiang Guo, MD, PhD

    Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 13, 2015

Study Start

January 1, 1998

Primary Completion

June 1, 2013

Study Completion

October 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11