Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Nimotuzumab; Radiation: VMAT

• Registration Number: NCT03915132
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2019-03-31
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-05-01
• Primary Completion: 2020-05-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VMAT plus Nimotuzumab	VMAT	Patients receive Nimotuzumab weekly during radiotherapy .
VMAT plus Nimotuzumab	Nimotuzumab	Patients receive Nimotuzumab weekly during radiotherapy .

Primary Outcome Measures

Name	Time	Method
Complete remission rate	4 months	Complete remission rate will be measured by RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
local control rate	2 years
regional control rate	2 years
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.
late treatment toxicity	2 years	late toxicity will be measured by CTCAE4.0

Trial Locations

Locations (1)

Cancer hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijin, China