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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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maintenance arm

Gemcitabine maintenance treatment

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

Gemcitabine maintenance chemotherapy

standard chemoradiotherapy

Intervention Type RADIATION

standard chemoradiotherapy

control arm

observe and follow-up

Group Type SHAM_COMPARATOR

standard chemoradiotherapy

Intervention Type RADIATION

standard chemoradiotherapy

Interventions

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Gemcitabine

Gemcitabine maintenance chemotherapy

Intervention Type DRUG

standard chemoradiotherapy

Intervention Type RADIATION

Other Intervention Names

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standard chemoradiotherapy

Eligibility Criteria

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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