Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

  • STATUS
    Recruiting
  • End date
    Apr 1, 2026
  • participants needed
    380
  • sponsor
    Sun Yat-sen University
Updated on 11 May 2022
carcinoma
induction chemotherapy
chemotherapy regimen
intensity-modulated radiation therapy
nasopharyngeal carcinoma

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

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 radiotherapy plus cisplatin concurrent chemotherapy. The enrolled patients will receive 2 cycles of cisplatin-based induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be randomised assigned to received 60 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

Details
Condition Nasopharyngeal Carcinoma
Treatment IMRT, induction chemotherapy, cisplatin concurrent chemotherapy
Clinical Study IdentifierNCT05304468
SponsorSun Yat-sen University
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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