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Active, not recruiting Phase 3

Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

NCT05304468 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2022-05-11
Last updated
2025-03-21

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

IMRTinduction chemotherapycisplatin concurrent chemotherapy

IMRT: Patients in experimental group received reduced dose IMRT

induction chemotherapy: cisplatin-based induction chemotherapy for two cycles

cisplatin concurrent chemotherapy: cisplatin 100mg/m2, for two(60Gy) or three cycles(70Gy)

Study 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 radiation therapy plus concurrent cisplatin chemotherapy

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III). 2. Stage II-III(8thAJCC/UICC staging system) 3. Aged 18-70 years 4. ECOG = 0-1 5. HGB≥90 g/L,WBC≥4×109 /L,PLT≥100×109 /L 6. ALT,AST\<1.5 x ULN;TBIL\<1.5×ULN 7. CCR≥60ml/min or Cr\<1.5×ULN 8. CR/PR and EBVDNA undetectable after induction chemotherapy 9. Signed informed consent Exclusion Criteria: 1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma 2. Age \<18 or \>70years 3. Treatment with palliative intent 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer 5. Pregnancy or lactation 6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume) 7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes 8. 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

Primary outcome measure(s)

  • PFS (progression-free survival) — 2 year
    Defined as the time from randomization to documented disease recurrence (either distant metastasis or locoregional disease recurrence) or death from any cause, whichever occurred first.

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Universitty Cancer Center Guangzhou Guangdong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05304468 on ClinicalTrials.gov ↗ ← All trials in China