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

• Sponsor: Zhejiang Cancer Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03025958
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 35
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: Nimotuzumab; Radiation: Radiation	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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; Radiation: Radiation

Outcome Measures

Primary Outcome Measures

1. Toxicity was graded according to the National Cancer Institute-Common Toxicity Criteria for Adverse Events version 3.0. [an average of 3 months]

   Safety

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiaozhong Chen	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

• Zhejiang Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhejiang Cancer Hospital
• ClinicalTrials.gov Identifier: NCT03025958
• Other Study ID Numbers: ZJCH-2016-HN04
• First Posted: Jan 20, 2017
• Last Update Posted: Jan 20, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Nimotuzumab

Study Results

No Results Posted as of Jan 20, 2017