Back to resultsICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma
Primary Purpose
Locally Advanced Nasopharyngeal Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Induction Chemotherapy
Concurrent Chemotherapy
Definitive Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years old;
- Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;
- Stage T3-4N0-1 (according to the UICC/AJCC 8th);
- No distant metastasis;
- Have not received anti-cancer treatment in the past;
- ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;
- Adequate hematologic, hepatic and renal function.
Exclusion Criteria:
- The purpose of treatment is palliative;
- Diagnosed with other malignant tumors at the same time;
- Malignant tumor history;
- Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;
- Combined serious illness.
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Induction Chemotherapy+Chemoradiotherapy
Chemoradiotherapy
Arm Description
Outcomes
Primary Outcome Measures
FFS (Failure-free Survival)
Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
Secondary Outcome Measures
OS (Overall Survival)
Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
LRFS (Locoregional Recurrence-free Survival)
Defined as the time from randomization to local or regional recurrence. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence free. Patients not having an event will be censored at the date last seen alive.
DMFS (Distant Metastasis-free Survival)
Defined as the time of randomization to the appearance of distant metastasis. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and metastasis free. Patients not having an event will be censored at the date last seen alive.
AE (Adverse events)
Adverse events during the treatment period will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Late AE of radiotherapy will be assessed according to RTOG criteria.
Full Information
NCT ID
NCT05062005
First Posted
September 7, 2021
Last Updated
September 21, 2021
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT05062005
Brief Title
ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma
Official Title
Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Anticipated)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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
This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether concurrent chemoradiotherapy is not inferior to induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
447 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Induction Chemotherapy+Chemoradiotherapy
Arm Type
Other
Arm Title
Chemoradiotherapy
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Induction Chemotherapy
Intervention Description
Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.
Intervention Type
Drug
Intervention Name(s)
Concurrent Chemotherapy
Intervention Description
Cisplatin 100 mg/m², Q3w.
Intervention Type
Radiation
Intervention Name(s)
Definitive Radiotherapy
Intervention Description
For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).
Primary Outcome Measure Information:
Title
FFS (Failure-free Survival)
Description
Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
Time Frame
3 year
Secondary Outcome Measure Information:
Title
OS (Overall Survival)
Description
Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Time Frame
3 year
Title
LRFS (Locoregional Recurrence-free Survival)
Description
Defined as the time from randomization to local or regional recurrence. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence free. Patients not having an event will be censored at the date last seen alive.
Time Frame
3 year
Title
DMFS (Distant Metastasis-free Survival)
Description
Defined as the time of randomization to the appearance of distant metastasis. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and metastasis free. Patients not having an event will be censored at the date last seen alive.
Time Frame
3 year
Title
AE (Adverse events)
Description
Adverse events during the treatment period will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Late AE of radiotherapy will be assessed according to RTOG criteria.
Time Frame
3 year
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:
Age 18-65 years old;
Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;
Stage T3-4N0-1 (according to the UICC/AJCC 8th);
No distant metastasis;
Have not received anti-cancer treatment in the past;
ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;
Adequate hematologic, hepatic and renal function.
Exclusion Criteria:
The purpose of treatment is palliative;
Diagnosed with other malignant tumors at the same time;
Malignant tumor history;
Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;
Combined serious illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Wu, PHD
Phone
+862087755766
Email
wush77@mail.sysu.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guang Dong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuang Wu, PHD
Phone
+862087755766
Email
wush77@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma
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