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Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915132
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Li Gao, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Complete remission rate [ Time Frame: 4 months ]
    Complete remission rate will be measured by RECIST 1.1


Secondary Outcome Measures :
  1. acute treatment toxicity [ Time Frame: up to 16 weeks ]
    Acute toxicity will be measured by CTCAE4.0

  2. Quality of Life Assessment [ Time Frame: 2 years ]
    EORTC,QLQ-C30 Version 3.0 are used.

  3. local control rate [ Time Frame: 2 years ]
  4. regional control rate [ Time Frame: 2 years ]
  5. late treatment toxicity [ Time Frame: 2 years ]
    late toxicity will be measured by CTCAE4.0



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915132


Contacts
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Contact: ye zhang, MD 8610-87787625 drzye1983@163.com
Contact: Junlin Yi, M.D 861087788504 junlinyi@sohu.com

Locations
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China
Cancer hospital, Chinese Academy of Medical Sciences Recruiting
Beijin, China, 100021
Contact: Ye Zhang    8610-87787625 ext 13717635880    drzye1983@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Ye Zhang, professor CAMS
Publications of Results:
Other Publications:
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Responsible Party: Li Gao, Chief physician, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03915132    
Other Study ID Numbers: NCC1937
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li Gao, Chinese Academy of Medical Sciences:
VMAT
Nimotuzumab
Elderly Patients
efficacy
toxicity
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents