Back to resultsDe-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Toxicities reduced treatment
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, De-escalation
Eligibility Criteria
Inclusion Criteria:
- Histological diagnosis of nasopharyngeal carcinoma
- Stage III or IVA according to UICC/AJCC 8th staging system
- Age ≥18
- No prior anti-tumor treatment
- Karnofsky Performance Score (KPS)≥70
- Adequate blood supply
- Informed consent obtained
Exclusion Criteria:
- Can not take contrast-MRI imaging
- Pregnant
- Combined with other malignant tumor (except basal cell carcinoma of skin)
Sites / Locations
- Fudan Universtiy Shanghai Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Toxicities reduced treatment
Conventional treatment
Arm Description
Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).
Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR).
Outcomes
Primary Outcome Measures
DFS
Disease Free Survival
Secondary Outcome Measures
OS
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04158518
Brief Title
De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title
De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chaosu Hu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma, De-escalation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Toxicities reduced treatment
Arm Type
Experimental
Arm Description
Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR).
Intervention Type
Radiation
Intervention Name(s)
Toxicities reduced treatment
Intervention Description
Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.
Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).
Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.
Intervention Type
Radiation
Intervention Name(s)
Conventional treatment
Intervention Description
Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.
Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR).
Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor.
Primary Outcome Measure Information:
Title
DFS
Description
Disease Free Survival
Time Frame
3 year
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological diagnosis of nasopharyngeal carcinoma
Stage III or IVA according to UICC/AJCC 8th staging system
Age ≥18
No prior anti-tumor treatment
Karnofsky Performance Score (KPS)≥70
Adequate blood supply
Informed consent obtained
Exclusion Criteria:
Can not take contrast-MRI imaging
Pregnant
Combined with other malignant tumor (except basal cell carcinoma of skin)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youqi Yang, MD
Phone
+8613916162859
Email
yangyq@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xueguan Lu, MD
Phone
+8618121299382
Email
luxueguan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaosu Hu, MD
Organizational Affiliation
Fudan University Shanghai Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan Universtiy Shanghai Cancer Centre
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youqi Yang, MD
Phone
+8613916162859
Email
yangyq@sina.com
First Name & Middle Initial & Last Name & Degree
Xueguan Lu, MD
Phone
+8618121299382
Email
luxueguan@163.com
12. IPD Sharing Statement
Learn more about this trial
De-escalation Protocols in Locoregionally Advanced Nasopharyngeal Carcinoma
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