Lower-dose (40.2 Gy) versus standard-dose (49.2 Gy) radiotherapy to low‑risk areas for chemosensitive Stage II nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 trial enrolls low‑risk, chemosensitive Stage II nasopharyngeal carcinoma patients who achieve a complete or partial response and undetectable plasma EBV DNA after induction cisplatin‑based chemotherapy plus PD‑1 immunotherapy. Eligible patients are randomized 1:1 to receive either reduced‑dose radiotherapy (40.2 Gy) or conventional‑dose radiotherapy (49.2 Gy) to the low‑risk clinical target volume (CTV2), with both arms receiving a full course of immunotherapy. Investigators will follow participants for survival outcomes, acute and late adverse events, and health‑related quality of life. The trial tests whether lowering the dose to CTV2 can preserve cancer control while reducing treatment‑related toxicity and improving quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients are informed of the basic content of this study and sign an informed consent form;
2. Age between 18 and 75 years;
3. Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III);
4. Staged according to the 9th edition of the AJCC/UICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II);
5. KPS ≥ 70;
6. Normal bone marrow function: WBC ≥ 4 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L;
7. Imaging evaluation of treatment response after three cycles of GPP/TPP induction chemotherapy plus immunotherapy: CR or PR;
8. Plasma EBV DNA level decreases to 0 copies/mL or below the detection limit after induction chemotherapy;
9. Normal liver and kidney function: total bilirubin, AST, ALT ≤ 2.0 times the upper limit of normal, creatinine clearance ≥ 60 mL/min or creatinine ≤ 1.5 times the upper limit of normal.

Exclusion Criteria:

1. Patients with recurrent/metastatic nasopharyngeal carcinoma;
2. Pregnant or breastfeeding women (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasised during treatment);
3. 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;
4. 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;
5. Patients with other severe medical conditions that may pose significant risks or impair trial compliance. Examples include unstable cardiac disease requiring treatment, renal disease, hepatic disease, uncontrolled diabetes (fasting blood glucose \> 1.5 × ULN), severe psychiatric disorders, or other malignant tumours;
6. Patients with a history of severe hypersensitivity reactions to any component of PD-1 monoclonal antibodies;
7. History of allergic reactions to the chemotherapy drugs used in this study (gemcitabine, docetaxel, albumin-bound paclitaxel, paclitaxel, cisplatin);
8. Patients with comorbidities requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects;
9. Patients with active tuberculosis, or those currently receiving antituberculosis treatment or who have received antituberculosis treatment within the past year prior to screening;
10. Other patients deemed ineligible for inclusion by the treating physician.

Where it's running

• Anhui Provincial Cancer Hospital
  Hefei, Anhui, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Sun Yat-sen University cancer center
  Guangzhou, Guangdong, China Recruiting
• the Affiliated Cancer Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Cancer Hospital of Shantou University Medical College
  Shantou, Guangdong, China Recruiting
• Zhongshan City People's Hospital
  Zhongshan, Guangdong, China Recruiting

Study contacts

• Principal investigator: Ming-Yuan Chen, MD,PhD — Sun Yat-sen University
• Study coordinator: Ming-Yuan Chen, MD,PhD
• Email: chenmy@sysucc.org.cn
• Phone: +86-20-87343361

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.