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

Study Overview
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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.

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.

Official Title
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A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Gemcitabine
* Radiation: standard chemoradiotherapy


Participation Criteria
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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 Exclusion Criteria: Pathology: WHO I Pregnant Combined with other malignant tumor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: maintenance arm<br>Gemcitabine maintenance treatment | Drug: Gemcitabine<br>* Gemcitabine maintenance chemotherapy<br>* Other names: standard chemoradiotherapy;Radiation: standard chemoradiotherapy<br>* standard chemoradiotherapy<br>|
| Sham Comparator: control arm<br>observe and follow-up | Radiation: standard chemoradiotherapy<br>* standard chemoradiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant metastatic free survival | from enrollment to distant metastatis | 5 year |