Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage

Phase 3

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Gemcitabine; Radiation: standard chemoradiotherapy

• Registration Number: NCT03403829
• Lead Sponsor: Fudan University

Brief Summary

Up to now, IMRT has largely improved the local control of locally advanced nasopharyngeal carcinoma (NPC), leaves the distant metastasis as the main treatment failure modality of patients with bulky lymph nodes (especially N3 stage). Although concurrent chemoradiotherapy (CCRT) continues to stand as the standard treatment of these patients, the role of adjuvant chemotherapy remains controversial due to its relatively severe toxicities and inferior compliance. However, our retrospective study of 2D-RT and IMRT era had proved adjuvant chemotherapy played key role in N3 NPC patients in terms of reducing distant metastasis and improving overall survival. Maintenance chemotherapy of gemicitabine single drug is promising with adequate efficacy and moderate toxicities. So we aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

Detailed Description

We aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-27
• Study Start: 2018-01-01
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• AJCC/UICC 8th edition N3 nasopharyngeal carcinoma
• Pathology: WHO II/II
• No prior anti-tumor treatment
• Age 18-60
• KPS≥70
• Adequate blood supply
• Informed consent obtained

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Exclusion Criteria

• Pathology: WHO I
• Pregnant
• Combined with other malignant tumor

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
maintenance arm	standard chemoradiotherapy	Gemcitabine maintenance treatment
control arm	standard chemoradiotherapy	observe and follow-up
maintenance arm	Gemcitabine	Gemcitabine maintenance treatment

Primary Outcome Measures

Name	Time	Method
Distant metastatic free survival	5 year	from enrollment to distant metastatis

Trial Locations

Locations (1)

Fudan Universtiy Shanghai Cancer Centre; 🇨🇳 Shanghai, Shanghai, China