Reduced Dose Radiotherapy vs Standard Dose Radiotherapy for Early Stage Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHai-Qiang Mai,MD,PhD

About this trial

This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy.

Eligibility criteria

Qualifiers

Age 18-70, regardless of sex.

Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I (according to the 9th American Joint Committee on Cancer[AJCC] edition).

Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gy radiation.

ECOG (Eastern Cooperative Oncology Group) score: 0-1.

Disqualifiers

Histologically confirmed keratinizing squamous cell carcinoma (WHO I).

Patients with PR/SD/PD according to RECIST and/or EBV DNA detectable after received 50.88Gy radiation.

Receiving radiotherapy or chemotherapy or targeted therapy previously.

Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.

Trial design

Treatments tested in this trial

  • Reduced dose radiation
  • Standard dose radiation

Treatment groups

342 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hai-Qiang Mai,MD,PhD

Lead sponsor

Sun Yat-sen University

Sponsor institution