Actively Recruiting
Induction Chemotherapy Plus Chemoradiotherapy versus Chemoradiotherapy Alone for Locally Advanced Nasopharyngeal Carcinoma
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2021-09-30
447
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatment options for patients with locally advanced nasopharyngeal carcinoma. This phase III trial compares two approaches: concurrent chemoradiotherapy alone versus induction chemotherapy followed by concurrent chemoradiotherapy. The goal is to determine if the combined approach is not worse than concurrent chemoradiotherapy by itself for this condition. The study is sponsored by the First Affiliated Hospital, Sun Yat-Sen University. Participants are assigned randomly to one of two groups. One group receives induction chemotherapy using regimens such as TP, TPF, or GP administered every three weeks, followed by concurrent chemotherapy with cisplatin every three weeks alongside radiotherapy. Radiotherapy is given once daily, five times per week, with a total dose of 66 to 70 Gy. The other group receives concurrent chemoradiotherapy without induction chemotherapy. During the study, participants are monitored for three years to assess failure-free survival as the primary outcome. Secondary outcomes include overall survival, locoregional recurrence-free survival, distant metastasis-free survival, and adverse events. Researchers evaluate participants’ health regularly through clinical assessments during this period to understand how each treatment approach affects these outcomes.
CONDITIONS
Brief Title
ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 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 performance status 0-1
- Adequate blood, liver, and kidney function
You will not qualify if you...
- Treatment intended only for symptom relief (palliative)
- Diagnosis of other malignant tumors at the same time
- History of malignant tumors
- Pregnancy, breastfeeding, or plans to become pregnant during the trial
- Presence of serious combined illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 to 10 weeks
Participants receive either induction chemotherapy followed by chemoradiotherapy or chemoradiotherapy alone to treat nasopharyngeal carcinoma.
Weekly visits during radiotherapy; chemotherapy visits every 3 weeks
Duration - Up to 3 years
Participants are monitored for treatment outcomes and adverse events after completing treatment.
Regular follow-up visits during 3 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
S
Shuang Wu, PHD
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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