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Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
VMAT
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring VMAT, Nimotuzumab, Elderly Patients, efficacy, toxicity

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cancer hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VMAT plus Nimotuzumab

Arm Description

Patients receive Nimotuzumab weekly during radiotherapy .

Outcomes

Primary Outcome Measures

Complete remission rate
Complete remission rate will be measured by RECIST 1.1

Secondary Outcome Measures

acute treatment toxicity
Acute toxicity will be measured by CTCAE4.0
Quality of Life Assessment
EORTC,QLQ-C30 Version 3.0 are used.
local control rate
regional control rate
late treatment toxicity
late toxicity will be measured by CTCAE4.0

Full Information

First Posted
March 31, 2019
Last Updated
January 28, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03915132
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
VMAT, Nimotuzumab, Elderly Patients, efficacy, toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VMAT plus Nimotuzumab
Arm Type
Experimental
Arm Description
Patients receive Nimotuzumab weekly during radiotherapy .
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Other Intervention Name(s)
Taixinsheng
Intervention Description
Nimotuzumab 200mg/m2 IV on d1 of a week before radiotherapy , and 100mg/m2 IV on d1 weekly for 7 cycles
Intervention Type
Radiation
Intervention Name(s)
VMAT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete remission rate
Description
Complete remission rate will be measured by RECIST 1.1
Time Frame
4 months
Secondary Outcome Measure Information:
Title
acute treatment toxicity
Description
Acute toxicity will be measured by CTCAE4.0
Time Frame
up to 16 weeks
Title
Quality of Life Assessment
Description
EORTC,QLQ-C30 Version 3.0 are used.
Time Frame
2 years
Title
local control rate
Time Frame
2 years
Title
regional control rate
Time Frame
2 years
Title
late treatment toxicity
Description
late toxicity will be measured by CTCAE4.0
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ye zhang, MD
Phone
8610-87787625
Email
drzye1983@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junlin Yi, M.D
Phone
861087788504
Email
junlinyi@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Zhang, professor
Organizational Affiliation
CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer hospital, Chinese Academy of Medical Sciences
City
Beijin
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Zhang
Phone
8610-87787625
Ext
13717635880
Email
drzye1983@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
29155480
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.
Results Reference
background
PubMed Identifier
23521779
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.
Results Reference
background
PubMed Identifier
24115004
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.
Results Reference
result
PubMed Identifier
29409313
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.
Results Reference
result

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Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma

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