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NCT03025958 Clinical Trial

Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Concurrent Nimotuzumab and Intensity-modulated Radiotherapy for Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03025958
Other study ID # ZJCH-2016-HN04
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 13, 2017
Est. completion date December 30, 2023

Study information
Verified date May 2024
Source Zhejiang Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Description:

Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 30, 2023
Est. primary completion date November 12, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma Exclusion Criteria: - A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions, supposed to live less than 6 months.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nimotuzumab
Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.
Radiation:
• Radiation
Briefly, the dose prescribed was 70.4 Gy, 70.4 Gy, 60.8 Gy, and 54.4 Gy in 32 fractions delivered over 6 weeks at the periphery of the planning target volume (PTV)nx+rn, PTVnd, PTV1, and PTV2, respectively, using the simultaneous integrated boost technique.

Locations
Country Name City State
China Xiaozhong Chen Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete response (CR) rate at 1 month after radiotherapy CR was defined as a complete lack of unequivocal soft tissue mass in the primary site and cervical lymph nodes with a short axis of less than 10 mm assessed by fiber-optic nasopharyngoscopy and MRI of the head and neck according to the Response Evaluation Criteria in Solid Tumors V.1.1 (RECIST V.1.1). 1 month after radiotherapy
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