Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07328854

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

Led by Ming-Yuan Chen · Updated on 2026-01-09

346

Participants Needed

15

Research Sites

344 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 75 years
  • Pathologically confirmed non-keratinising nasopharyngeal carcinoma (WHO type II or III)
  • Stage II nasopharyngeal carcinoma classified as T1-3N2M0 or T3N0-1M0
  • Karnofsky Performance Status (KPS) score of 70 or higher
  • Normal bone marrow function (WBC ≥ 4 x 10⁹/L, PLT ≥ 100 x 10⁹/L, HGB ≥ 90 g/L)
  • Achieved complete or partial response after three cycles of gemcitabine plus cisplatin induction chemotherapy with immunotherapy
  • Plasma EBV DNA level reduced to zero or below detection limit after induction chemotherapy
  • Normal liver and kidney function (bilirubin, AST, ALT ≤ 2 times upper limit; creatinine clearance ≥ 60 mL/min or creatinine ≤ 1.5 times upper limit)
Not Eligible

You will not qualify if you...

  • Recurrent or metastatic nasopharyngeal carcinoma
  • Pregnant or breastfeeding women
  • History of malignant tumors except certain cured cancers (cervical, skin basal cell or squamous cell, localized prostate, or ductal carcinoma in situ)
  • Previous radiotherapy or surgery (except diagnostic) to local lesions or lesions with necrosis unsuitable for radiotherapy
  • Severe medical conditions that increase risk or affect compliance (unstable cardiac disease, renal/hepatic disease, uncontrolled diabetes, severe psychiatric disorders, other malignancies)
  • History of severe allergic reactions to PD-1 monoclonal antibodies
  • Allergic reactions to chemotherapy drugs used in the study (gemcitabine, docetaxel, paclitaxel variants, cisplatin)
  • Need for long-term immunosuppressive therapy or corticosteroids with immunosuppressive effects
  • Active tuberculosis or treatment for tuberculosis within the past year
  • Other conditions making the patient ineligible as judged by the treating physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Actively Recruiting

2

Fujian Cancer Hospital

Fuzhou, Fujian, China

Actively Recruiting

3

Sun Yat-sen University cancer center

Guangzhou, Guangdong, China

Actively Recruiting

4

the Affiliated Cancer Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Actively Recruiting

5

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Actively Recruiting

6

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

Actively Recruiting

7

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Actively Recruiting

8

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Actively Recruiting

9

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

Actively Recruiting

10

Central South University Cancer Hospital,

Changsha, Hunan, China

Actively Recruiting

11

Xiangya Hospital of Central South University

Changsha, Hunan, China

Actively Recruiting

12

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Actively Recruiting

13

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Actively Recruiting

14

Yunnan Cancer Hospital

Kunming, Yunnan, China

Actively Recruiting

15

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

M

Ming-Yuan Chen, MD,PhD

CONTACT

R

Rui You, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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