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

Phase 2

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Nimotuzumab; Radiation: Radiation

• Registration Number: NCT03025958
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-20
• Study Start: 2017-03-13
• Primary Completion: 2018-11-12
• Study Completion: 2023-12-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab	Radiation	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).
Nimotuzumab	Nimotuzumab	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).

Primary Outcome Measures

Name	Time	Method
Complete response (CR) rate at 1 month after radiotherapy	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).

Trial Locations

Locations (1)

Xiaozhong Chen; 🇨🇳 Hangzhou, Zhejiang, China