Status:
ACTIVE_NOT_RECRUITING
Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated ra...
Detailed Description
To explore the 2 year PFS of patients with stageII-III nasopharyngeal carcinoma treated with induction chemotherapy followed by reduced-dose radiotherapy and cisplatin versus standard dose radiotherap...
Eligibility Criteria
Inclusion
- Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III).
- Stage II-III（8thAJCC/UICC staging system)
- Aged 18-70 years
- ECOG = 0-1
- HGB≥90 g/L，WBC≥4×109 /L，PLT≥100×109 /L
- ALT,AST\<1.5 x ULN；TBIL\<1.5×ULN
- CCR≥60ml/min or Cr\<1.5×ULN
- CR/PR and EBVDNA undetectable after induction chemotherapy
- Signed informed consent
Exclusion
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma
- Age \<18 or \>70years
- Treatment with palliative intent
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
- Pregnancy or lactation
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume)
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2029
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT05304468
Start Date
May 11 2022
End Date
October 29 2029
Last Update
March 21 2025
Active Locations (1)
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1
Sun Yat-sen Universitty Cancer Center
Guangzhou, Guangdong, China, 510060