Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT05062005
Recruiting Phase 3

ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

NCT05062005 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Phase
Phase 3
Started
2021-09-22
Last updated
2021-09-30

Condition(s) studied

Locally Advanced Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

Induction ChemotherapyConcurrent ChemotherapyDefinitive Radiotherapy

Induction Chemotherapy: 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.

Concurrent Chemotherapy: Cisplatin 100 mg/m², Q3w.

Definitive Radiotherapy: For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-65 years old; 2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 3. Stage T3-4N0-1 (according to the UICC/AJCC 8th); 4. No distant metastasis; 5. Have not received anti-cancer treatment in the past; 6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1; 7. Adequate hematologic, hepatic and renal function. Exclusion Criteria: 1. The purpose of treatment is palliative; 2. Diagnosed with other malignant tumors at the same time; 3. Malignant tumor history; 4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period; 5. Combined serious illness.

Primary outcome measure(s)

  • FFS (Failure-free Survival) — 3 year
    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.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting

More First Affiliated Hospital, Sun Yat-Sen University trials in China

A Simulated Case Study of a Peritoneal Dialysis-Specialized Large Language Model Assisting Doctors in Improving Decision-Making in Peritoneal Dialysis Management Enrolling by invitation
Peritoneal Dialysis (PD) Specialized LLM for PD Management Enrolling by invitation
Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial Recruiting
Efficacy and Safety of Reperfusion Therapy for Minor Ischemic Stroke in China Starting soon
To Develop and Validate a Nasoendoscopic Intelligent Diagnostic System for Nasopharyngeal Carcinoma Recruiting

Other trials for the same condition

Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma Recruiting
Iparomlimab/Tuvorlimab (QL1706) and Modified TPF Regimen for Induction Therapy in LANPC Recruiting
Sintilimab Combined With Bevacizumab and TP Chemotherapy in the Treatment of High Risk Locally-advanced NPC Starting soon
Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma Recruiting
Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05062005 on ClinicalTrials.gov ↗ ← All trials in China