Actively Recruiting
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2024-08-06
454
Participants Needed
8
Research Sites
312 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
First Affiliated Hospital of Guangxi Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).
CONDITIONS
Official Title
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years old
- Newly confirmed histological diagnosis of non-keratinizing nasopharyngeal carcinoma
- Tumor stage III-IVa excluding T4N2 or any TN3 according to the 8th AJCC edition
- Pretreatment plasma Epstein-Barr virus DNA less than 4000 copies/ml
- ECOG performance status of 0 or 1
- Male or non-pregnant female
- Adequate bone marrow function: leucocyte count ≥ 4000/µL, hemoglobin ≥ 90 g/L, platelet count ≥ 100000/µL
- Normal liver function tests: ALT and AST less than 1.5 times upper limit of normal, ALP less than 2.5 times upper limit, bilirubin below upper limit
- Adequate kidney function with creatinine clearance ≥ 60 ml/min
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Evidence of cancer relapse or distant metastasis
- Diagnosis of keratinizing or basaloid squamous cell carcinoma
- Treatment intended only for symptom relief (palliative intent)
- Previous radiotherapy except for non-melanoma skin cancers outside the treatment area
- Prior chemotherapy or surgery for the primary tumor or lymph nodes except diagnostic procedures
- Pregnancy or breastfeeding
- History of other cancers except treated basal cell or squamous skin cancer or in situ cervical cancer
- Severe health conditions that increase risk or affect trial participation, including unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, or emotional disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
3
Zhongshan City People's Hospital
Zhongshan, Guangdong, China, 528499
Not Yet Recruiting
4
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Not Yet Recruiting
5
Cancer Hospital of Guizhou Province
Guiyang, Guizhou, China
Not Yet Recruiting
6
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
7
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology;
Wuhan, Hubei, China
Not Yet Recruiting
8
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
Research Team
H
Hai-Qiang Mai
CONTACT
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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