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

NCT03025958 | Completed Phase 2 DMC

• 1 other identifier: ZJCH-2016-HN04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Nimotuzumab

EXPERIMENTAL

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

Interventions

Nimotuzumab DRUG

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

Also known as: humanized anti-epidermal factor receptor monoclonal antibody h-R3

Nimotuzumab

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.

Nimotuzumab

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Xiaozhong Chen

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nimotuzumab; Radiation

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Xiaozhong Chen, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department

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

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 20, 2017
• Study Start: March 13, 2017
• Primary Completion: November 12, 2018
• Study Completion: December 30, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)