Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma of pretreatment EBV DNA<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cisplatin

Criteria

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) and pretreatment EBVDNA<4000opies/ml

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