Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma

Phase II Trial of Nimotuzumab Combined With Volumetric Modulated Arc Therapy in Elderly Patients With Nasopharyngeal Carcinoma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03915132

Enrollment

Registered

2019-04-16

Start date

2019-05-01

Completion date

2022-05-01

Last updated

2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

VMAT, Nimotuzumab, Elderly Patients, efficacy, toxicity

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.

Detailed description

The incidence of elderly patients with nasopharyngeal carcinoma is increasing with a rapidly ageing population. However, the prognosis is worse than that of young patients. Some patients can benefit from intensive treatment such as concurrent chemoradiotherapy, but are always with obvious toxicity. With the advancement of radiotherapy technology and the emergence of molecular targeted drugs, radiotherapy combined with Nimotuzumab has shown good therapeutic efficacy and tolerance. The investigators plan to testify VMAT combined with Nimotuzumab in elderly patients with nasopharyngeal carcinoma.

Interventions

DRUGNimotuzumab

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

RADIATIONVMAT

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Complete remission rate	4 months	Complete remission rate will be measured by RECIST 1.1

Secondary

Measure	Time frame	Description
acute treatment toxicity	up to 16 weeks	Acute toxicity will be measured by CTCAE4.0
Quality of Life Assessment	2 years	EORTC,QLQ-C30 Version 3.0 are used.
local control rate	2 years	—
regional control rate	2 years	—
late treatment toxicity	2 years	late toxicity will be measured by CTCAE4.0

Countries

China

Contacts

Primary Contactye zhang, MD

drzye1983@163.com8610-87787625

Backup ContactJunlin Yi, M.D

junlinyi@sohu.com861087788504

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026