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

May 2, 2024 updated by: Chen Xiaozhong, Zhejiang Cancer Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Xiaozhong Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Nimotuzumab
Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.
Other Names:
  • humanized anti-epidermal factor receptor monoclonal antibody h-R3
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response (CR) rate at 1 month after radiotherapy
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Xiaozhong Chen, MD, Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2017

Primary Completion (Actual)

November 12, 2018

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimated)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJCH-2016-HN04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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