Back to resultsChemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Loco-regional Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Initially, Untreated, Distant metastatic
Eligibility Criteria
Inclusion Criteria:
- The patients with initial untreated metastatic nasopharyngeal carcinoma
- Histologic diagnosis of nasopharyngeal carcinoma
- T1-4N0-3M1,IVC(according to the 7th AJCC edition)
- Aged between 18 and 65 years
- KPS≥70
- The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu
- Voluntary to participate and sign informed consent document
Exclusion Criteria:
- The patients suffered from serious neurologic disease
- Clinically significant cardiac, heart function less than or equal to 3 level
- Clinically significant respiratory disease,lung function less than or equal to 3 level
- Blood routine examination: WBC<3×109/L, Hemoglobin<90g/L, platelet count<75×109/L
- Abnormal liver function: total bilirubin or ALT or AST>2×ULN
- Abnormal renal function:serum creatinine>1.5×ULN
- Pregnant or lactating women
- The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu
Sites / Locations
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radiotherapy
Chemotherapy
Arm Description
Systemic Chemotherapy Combined with Loco-regional Radiotherapy
Chemotherapy alone without Loco-regional Radiotherapy
Outcomes
Primary Outcome Measures
Overall survival
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Secondary Outcome Measures
Progress-free survival
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
Complete Response (CR)
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
Full Information
NCT ID
NCT02111460
First Posted
April 9, 2014
Last Updated
May 6, 2020
Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02111460
Brief Title
Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma
Official Title
Multicentre Randomization Clinic Trial of Systemic Chemotherapy Combined With Loco-regional Radiotherapy vs. Chemotherapy Alone for Initially Untreated Distant Metastatic Nasopharyngeal Carcinoma With Chemosensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized parallel control trial to evaluate whether radical loco-regional Radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Initially, Untreated, Distant metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy
Arm Type
Experimental
Arm Description
Systemic Chemotherapy Combined with Loco-regional Radiotherapy
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Chemotherapy alone without Loco-regional Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Loco-regional Radiotherapy
Intervention Description
with or without Loco-regional Radiotherapy
Primary Outcome Measure Information:
Title
Overall survival
Description
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progress-free survival
Description
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
Time Frame
2 years
Title
Complete Response (CR)
Description
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
Time Frame
after the completion of the chemoradiotherapy treatment (up to 9 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with initial untreated metastatic nasopharyngeal carcinoma
Histologic diagnosis of nasopharyngeal carcinoma
T1-4N0-3M1,IVC(according to the 7th AJCC edition)
Aged between 18 and 65 years
KPS≥70
The therapeutic effect evaluation is CR or PR accomplished three course of cisplatin and 5-Fu
Voluntary to participate and sign informed consent document
Exclusion Criteria:
The patients suffered from serious neurologic disease
Clinically significant cardiac, heart function less than or equal to 3 level
Clinically significant respiratory disease,lung function less than or equal to 3 level
Blood routine examination: WBC<3×109/L, Hemoglobin<90g/L, platelet count<75×109/L
Abnormal liver function: total bilirubin or ALT or AST>2×ULN
Abnormal renal function:serum creatinine>1.5×ULN
Pregnant or lactating women
The therapeutic effect evaluation is SD or PD accomplished three course of cisplatin and 5-Fu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming y Chen, MD,Phd
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
32701129
Citation
You R, Liu YP, Huang PY, Zou X, Sun R, He YX, Wu YS, Shen GP, Zhang HD, Duan CY, Tan SH, Cao JY, Li JB, Xie YL, Zhang YN, Wang ZQ, Yang Q, Lin M, Jiang R, Zhang MX, Hua YJ, Tang LQ, Zhuang AH, Chen QY, Guo L, Mo HY, Chen Y, Mai HQ, Ling L, Liu Q, Chua MLK, Chen MY. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1345-1352. doi: 10.1001/jamaoncol.2020.1808.
Results Reference
derived
Learn more about this trial
Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma
We'll reach out to this number within 24 hrs