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

NCT ID: NCT03025958

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-13

Study Completion Date

2023-12-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Nimotuzumab

Intervention Type DRUG

Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.

Radiation

Intervention Type 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.

Interventions

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Nimotuzumab

Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.

Intervention Type DRUG

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.

Intervention Type RADIATION

Other Intervention Names

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humanized anti-epidermal factor receptor monoclonal antibody h-R3

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Xiaozhong

Director of department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaozhong Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Xiaozhong Chen

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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ZJCH-2016-HN04

Identifier Type: -

Identifier Source: org_study_id

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