Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma

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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

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Complete remission rate

Secondary Outcome

 acute treatment toxicity

Condition

Nasopharyngeal Carcinoma

Intervention

Nimotuzumab

Study Arms / Comparison Groups

 VMAT plus Nimotuzumab
Description:  Patients receive Nimotuzumab weekly during radiotherapy .

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

47

Start Date

May 1, 2019

Completion Date

May 1, 2022

Primary Completion Date

May 1, 2020

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.

Gender

All

Ages

70 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ye Zhang, professor, 8610-87787625, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03915132

Organization ID

NCC1937

Responsible Party

Principal Investigator

Study Sponsor

Chinese Academy of Medical Sciences

Study Sponsor

Ye Zhang, professor, Principal Investigator, CAMS

Verification Date

April 2019