Clinical trial NCT03915132: Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma
Official title: Phase II Trial of Nimotuzumab Combined With Volumetric Modulated Arc Therapy in Elderly Patients With Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: VMAT
Nimotuzumab
Elderly Patients
efficacy
toxicity
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2019-04-16
Enrollment: 47
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete remission rate
timeFrame: 4 months
Secondary outcomes:
measure: acute treatment toxicity
timeFrame: up to 16 weeks
measure: Quality of Life Assessment
timeFrame: 2 years
measure: local control rate
timeFrame: 2 years
measure: regional control rate
timeFrame: 2 years
measure: late treatment toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijin
country: China
facility: Cancer hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: CAMS
name: Ye Zhang, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.