Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT03915132

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: Nimotuzumab Radiation: VMAT	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VMAT plus Nimotuzumab Patients receive Nimotuzumab weekly during radiotherapy .	Drug: Nimotuzumab Nimotuzumab 200mg/m2 IV on d1 of a week before radiotherapy , and 100mg/m2 IV on d1 weekly for 7 cycles Other Names: Taixinsheng Radiation: VMAT 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.

Arm

Intervention/Treatment

Experimental: VMAT plus Nimotuzumab

Patients receive Nimotuzumab weekly during radiotherapy .

Drug: Nimotuzumab

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

Other Names:

Taixinsheng

Radiation: VMAT

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.

Outcome Measures

Primary Outcome Measures

Complete remission rate [4 months]
Complete remission rate will be measured by RECIST 1.1

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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.