NCT03837808

Brief Summary

This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2024

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

4.8 years

First QC Date

January 26, 2019

Last Update Submit

November 3, 2022

Conditions

Nasopharyngeal CarcinomaNasopharyngeal NeoplasmsNasopharyngeal DiseasesHead and Neck Neoplasm

Keywords

nimotuzumab

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival (PFS)

    Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

    2 years

Secondary Outcomes (4)

  • Overall Survival (OS)

    2 years

  • Locoregional Relapse-Free Survival (LRRFS)

    2 years

  • Distant Metastasis-Free Survival (DMFS)

    2 years

  • Number of participants with adverse events

    up to 2 years

Study Arms (2)

Nimotuzumab

EXPERIMENTAL

nimotuzumab 200mg/week in concurrent with IMRT

Drug: Nimotuzumab

Cisplatin

ACTIVE COMPARATOR

cisplatin 40mg/m2/week in concurrent with IMRT

Drug: Cisplatin

Interventions

NimotuzumabDRUG

nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT

Nimotuzumab
CisplatinDRUG

cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT

Cisplatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
  • histologically confirmed positive EGFR expression
  • Stage II and III NPC patients（according to the 8th AJCC edition）
  • Male and no pregnant female
  • Age between 18-65
  • Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
  • Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<2.0×upper limit of normal (ULN)
  • Adequate renal function: creatinine clearance ≥60 ml/min
  • Satisfactory performance status: Karnofsky scale (KPS) \> 70
  • Without radiotherapy or chemotherapy
  • Patients must give signed informed consent

You may not qualify if:

  • Evidence of relapse or distant metastasis
  • History of prior malignancy or previous treatment for NPC
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal CarcinomaNasopharyngeal NeoplasmsNasopharyngeal DiseasesHead and Neck Neoplasms

Interventions

nimotuzumabCisplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNeoplasms by SitePharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Ming-Yuan Chen, MD,PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yuan Chen, MD,PhD

CONTACT

+86-20-87343361chenmy@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2019

First Posted

February 12, 2019

Study Start

April 11, 2019

Primary Completion

February 11, 2024

Study Completion

February 11, 2024

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations

CN(1)