Actively Recruiting
Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant Chemotherpy
Led by Fudan University · Updated on 2023-01-10
366
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of EBV DNA. Participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their EBV DNA decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.
CONDITIONS
Official Title
Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant Chemotherpy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed non-keratinizing nasopharyngeal carcinoma, WHO type II or III
- Age between 18 and 70 years
- Clinical stage III to IVa based on the 8th AJCC edition
- Detectable plasma EBV DNA before treatment but undetectable after one cycle of neoadjuvant chemotherapy with no rebound during cycles two and three
- ECOG performance status score of 0 or 1
- Hemoglobin level of at least 90 g/L, white blood cell count at least 4 x 10^9/L, and platelet count at least 100 x 10^9/L
- Liver function with ALT and AST less than 1.5 times the upper limit of normal and total bilirubin less than 1.0 times the upper limit
- Renal function with serum creatinine less than the upper limit of normal
- Willingness and ability to sign informed consent and comply with study visits, treatment, and tests
You will not qualify if you...
- Histologically confirmed keratinizing squamous cell carcinoma (WHO type I)
- Previous diagnosis of other malignant tumors except cured basal cell carcinoma or cervical carcinoma in situ
- Prior radiotherapy, chemotherapy, or targeted therapy
- Women who are pregnant or breastfeeding
- Significant impairment of heart, liver, lung, kidney, or bone marrow function
- Severe uncontrolled medical conditions or infections
- Concurrent use of other experimental drugs or participation in other clinical trials
- Refusal or inability to provide informed consent
- Emotional disturbances, mental illness, or limited legal capacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan Universtiy Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
Chengrun Du, MD and PhD
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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