ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma
Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
1 other identifier
interventional
447
1 country
1
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.
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 Sep 2021
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2021
CompletedStudy Start
First participant enrolled
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
September 30, 2021
September 1, 2021
5.9 years
September 7, 2021
September 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 year
Secondary Outcomes (4)
OS (Overall Survival)
3 year
LRFS (Locoregional Recurrence-free Survival)
3 year
DMFS (Distant Metastasis-free Survival)
3 year
AE (Adverse events)
3 year
Study Arms (2)
Induction Chemotherapy+Chemoradiotherapy
OTHERChemoradiotherapy
OTHERInterventions
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.
Cisplatin 100 mg/m², Q3w.
For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
September 7, 2021
First Posted
September 30, 2021
Study Start
September 22, 2021
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
September 30, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share