Actively Recruiting
Two Cycles Versus Three Cycles Induction Chemotherapy Plus Concurrent Chemoradiotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2023-05-16
474
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether 2 cycles of induction chemotherapy combined with concurrent chemoradiotherapy is not worse than 3 cycles of induction chemotherapy combined with concurrent chemoradiotherapy for patients with locally advanced nasopharyngeal carcinoma. This phase III clinical trial focuses on adults aged 18 to 65 years with specific stages of nasopharyngeal carcinoma who have not previously received anti-cancer treatment. The study aims to determine if fewer chemotherapy cycles can provide similar outcomes in this patient group. The trial compares two treatment approaches: one group receives 2 cycles of induction chemotherapy, and the other receives 3 cycles, both followed by concurrent chemoradiotherapy. Induction chemotherapy regimens include TP (docetaxel and cisplatin), TPF (docetaxel, cisplatin, and 5-fluorouracil), or GP (gemcitabine and cisplatin), administered every three weeks. Concurrent chemotherapy uses cisplatin every three weeks, combined with definitive radiotherapy given once daily, five days a week, at a dose of 66-70 Gy. Participants will be monitored for treatment effects and outcomes over time, focusing primarily on failure-free survival at three years. Researchers will assess how well the treatments work in controlling the cancer without distant spread. Participants will undergo routine evaluations to track their health status, treatment adherence, and any side effects. The total study duration spans several years to capture long-term results and safety data.
CONDITIONS
Brief Title
Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years old
- Pathologically confirmed non-keratinizing nasopharyngeal carcinoma
- Stage T3-4N0-1 according to UICC/AJCC 8th edition
- No distant metastasis
- No prior anti-cancer treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood, liver, and kidney function
You will not qualify if you...
- Treatment aimed only for symptom relief (palliative)
- Diagnosis of other malignant tumors at the same time
- History of any malignant tumor
- Pregnancy, breastfeeding, or planning pregnancy during the trial period
- Presence of serious concurrent illness
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 9 weeks including induction chemotherapy cycles every 3 weeks and daily radiotherapy 5 times a week
Participants receive 2 or 3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy including cisplatin and definitive radiotherapy.
Multiple visits for chemotherapy and daily visits for radiotherapy 5 times a week
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Other (Non U.s.), China, 510080
Actively Recruiting
Research Team
C
Cheng-Tao Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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