NCT03915132

Brief Summary

To evaluate the efficacy and toxicity of Nimotuzumab combined with VMAT in the treatment of elderly patients with nasopharyngeal carcinoma (\> 70 years old), and to provide high-level clinical evidence for the optimal treatment of elderly patients with 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
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2019

Typical duration for phase_2

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

March 31, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

March 31, 2019

Last Update Submit

January 28, 2021

Conditions

Nasopharyngeal Carcinoma

Keywords

VMATNimotuzumabElderly Patientsefficacytoxicity

Outcome Measures

Primary Outcomes (1)

  • Complete remission rate

    Complete remission rate will be measured by RECIST 1.1

    4 months

Secondary Outcomes (5)

  • acute treatment toxicity

    up to 16 weeks

  • Quality of Life Assessment

    2 years

  • local control rate

    2 years

  • regional control rate

    2 years

  • late treatment toxicity

    2 years

Study Arms (1)

VMAT plus Nimotuzumab

EXPERIMENTAL

Patients receive Nimotuzumab weekly during radiotherapy .

Drug: NimotuzumabRadiation: VMAT

Interventions

NimotuzumabDRUG

Nimotuzumab 200mg/m2 IV on d1 of a week before radiotherapy , and 100mg/m2 IV on d1 weekly for 7 cycles

Also known as: Taixinsheng
VMAT plus Nimotuzumab
VMATRADIATION

Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx,69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume.

VMAT plus Nimotuzumab

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Pathology confirmed squamous cell carcinoma of nasopharynx; Aged ≥ 70 years old; Stage III-IVB diseases according to 8th AJCC Staging; Treatment for the first time; ECOG scores ≤ 1; Normal hepatic, renal and bone-marrow function; ACE-27 scores ≤2; Life expectancy≥12 weeks; Can understand and sign the consent.

You may not qualify if:

  • Past malignancies history (except for non-melanoma skin cancer or cervical carcinoma in situ or cured prostate cancer of early stage); Allergic to Nimotuzumab; Severe comorbidities including cardiovascular, cerebral vascular, mental and uncontrolled diabetes disease; Chemotherapy, surgery or other molecule-target treatment; Severe malnutrition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital, Chinese Academy of Medical Sciences

Beijin, 100021, China

RECRUITING

Related Publications (4)

  • Cao C, Hu Q, Chen X. Intensity-modulated radiotherapy for elderly patients with nasopharyngeal carcinoma. Head Neck. 2018 Mar;40(3):590-595. doi: 10.1002/hed.25016. Epub 2017 Nov 20.

    PMID: 29155480BACKGROUND

  • Liu H, Chen QY, Guo L, Tang LQ, Mo HY, Zhong ZL, Huang PY, Luo DH, Sun R, Guo X, Cao KJ, Hong MH, Mai HQ. Feasibility and efficacy of chemoradiotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma: results from a matched cohort analysis. Radiat Oncol. 2013 Mar 22;8:70. doi: 10.1186/1748-717X-8-70.

    PMID: 23521779BACKGROUND

  • Zhang Y, Yi JL, Huang XD, Xu GZ, Xiao JP, Li SY, Luo JW, Zhang SP, Wang K, Qu Y, Gao L. Inherently poor survival of elderly patients with nasopharyngeal carcinoma. Head Neck. 2015 Jun;37(6):771-6. doi: 10.1002/hed.23497. Epub 2015 Feb 11.

    PMID: 24115004RESULT

  • Jin YN, Zhang WJ, Cai XY, Li MS, Lawrence WR, Wang SY, Mai DM, Du YY, Luo DH, Mo HY. The Characteristics and Survival Outcomes in Patients Aged 70 Years and Older with Nasopharyngeal Carcinoma in the Intensity-Modulated Radiotherapy Era. Cancer Res Treat. 2019 Jan;51(1):34-42. doi: 10.4143/crt.2017.551. Epub 2018 Feb 6.

    PMID: 29409313RESULT

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ye Zhang, professor

    CAMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ye zhang, MD

CONTACT

8610-87787625drzye1983@163.com

Junlin Yi, M.D

CONTACT

861087788504junlinyi@sohu.com

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
Chief physician

Study Record Dates

First Submitted

March 31, 2019

First Posted

April 16, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2022

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

CN(1)