40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMing-Yuan Chen

About this trial

This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.

Eligibility criteria

Qualifiers

Patients are informed of the basic content of this study and sign an informed consent form;

Age between 18 and 75 years;

Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III);

Staged according to the 9th edition of the AJCC/UICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II);

Disqualifiers

Patients with recurrent/metastatic nasopharyngeal carcinoma;

Pregnant or breastfeeding women (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasised during treatment);

Patients with a history of malignant tumours, excluding those who have undergone curative treatment for cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ;

Patients whose local/regional lesions have undergone radiotherapy or surgery (excluding diagnostic surgery), or whose lesions exhibit significant necrosis, making radiotherapy unsuitable or potentially leading to radiotherapy resistance;

Trial design

Treatments tested in this trial

  • Cisplatin-based induction chemotherapy
  • Full course of PD-1 monoclonal antibody
  • Reduced-dose radiotherapy to CTV2
  • Conventional-dose radiotherapy to CTV2

Treatment groups

346 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ming-Yuan Chen

Lead sponsor

Sun Yat-sen University

Sponsor institution