Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain

Last updated: March 18, 2025
Sponsor: Sun Yat-sen University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

induction chemotherapy

cisplatin concurrent chemotherapy

IMRT

Clinical Study ID

NCT05304468
2022-FXY-017
  • Ages 18-70
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHOtype 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

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 outsideintended 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 thecompliance 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

Study Design

Total Participants: 452
Treatment Group(s): 3
Primary Treatment: induction chemotherapy
Phase: 3
Study Start date:
May 11, 2022
Estimated Completion Date:
October 29, 2029

Study 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 2 cycles of cisplatin concurrent chemotherapy or 70Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

Connect with a study center

  • Sun Yat-sen Universitty Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

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