Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Radiotherapy alone; Radiation: Concurrent chemoradiotherapy

• Registration Number: NCT03058432
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Detailed Description

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

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-16
• Last Update Submitted: 2017-02-16
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensity-modulated Radiotherapy	Radiotherapy alone	Radiotherapy alone was given.
Concurrent chemoradiotherapy	Concurrent chemoradiotherapy	Concurrent cisplatin-based radiotherapy was given.

Primary Outcome Measures

Name	Time	Method
therapeutic success	From date of treatment until the date of completing treatment 1 month later	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.

Trial Locations

Locations (1)

Xiaozhong Chen; 🇨🇳 Hangzhou, Zhejiang, China