Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03058432
• Other study ID #: ZJCH-2016-HN03
• Status: Recruiting
• Phase: Phase 2
• First received: February 16, 2017
• Last updated: February 16, 2017
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2017
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Description:

To evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Radiation:
• Radiotherapy alone

• Concurrent chemoradiotherapy

Locations

Country	Name	City	State
China	Xiaozhong Chen	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	therapeutic success	A combined primary end point, named "therapeutic success"(TS), was used; it took into account activity, toxicity, and compliance.A TS was defined as a patient completing radiotherapy at the planned dose and schedule (no re-treatment delays beyond 2 weeks), and having an objective response (either complete or partial based on RECIST criteria) without (1) grade 3-4 nonhematological toxicity, (2) complications associated with hematologic toxicity such as febrile neutropenia, infection, bleeding, or transfusion, or (3) any toxicity leading to hospitalization or death.	From date of treatment until the date of completing treatment 1 month later