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Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown
Phase 2

Conditions

Nasopharyngeal Carcinoma

Treatments

Radiation: VMAT
Drug: Nimotuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT03915132
NCC1937

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 estimated patients

Sex

All

Ages

70+ years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

47 participants in 1 patient group

VMAT plus Nimotuzumab
Experimental group
Description:
Patients receive Nimotuzumab weekly during radiotherapy .
Treatment:
Drug: Nimotuzumab
Radiation: VMAT

Trial contacts and locations

1

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Central trial contact

Junlin Yi, M.D; ye zhang, MD

Data sourced from clinicaltrials.gov

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