Brief Title
Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage
Official Title
A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Distant metastatic free survival
Condition
Nasopharyngeal Carcinoma
Intervention
Gemcitabine
Study Arms / Comparison Groups
maintenance arm
Description: Gemcitabine maintenance treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
360
Start Date
January 1, 2018
Completion Date
December 31, 2020
Primary Completion Date
December 31, 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Chaosu Hu, M.D, 862164175590, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03403829
Organization ID
2017-NPC001
Responsible Party
Principal Investigator
Study Sponsor
Fudan University
Study Sponsor
Chaosu Hu, M.D, Principal Investigator, Fudan University Shanghai cancer centre
Verification Date
July 2019