Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage
A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage
1 other identifier
interventional
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2018
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedFirst Posted
Study publicly available on registry
January 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 8, 2019
July 1, 2019
3 years
December 27, 2017
July 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Distant metastatic free survival
from enrollment to distant metastatis
5 year
Study Arms (2)
maintenance arm
EXPERIMENTALGemcitabine maintenance treatment
control arm
SHAM COMPARATORobserve and follow-up
Interventions
Gemcitabine maintenance chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pathology: WHO I
- Pregnant
- Combined with other malignant tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan Universtiy Shanghai Cancer Centre
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chaosu Hu, M.D
Fudan University Shanghai cancer centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 27, 2017
First Posted
January 19, 2018
Study Start
January 1, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
July 8, 2019
Record last verified: 2019-07