To evaluate whether the 2-year local failure-free survival (LRFFS) in Cohort 1 patients with AJCC/UICC 8th edition stage IB-II nasopharyngeal carcinoma who achieved EBV-DNA = 0 after induction chemotherapy and had MRI assessment of complete response (CR) or partial response (PR) ≥50% is non-inferior when treated with reduced-dose IMRT (59.4 Gy/27 fractions) compared to standard-dose IMRT (66.0 Gy/30 fractions).
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Age: 18 - 65 years old.
* Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing cancer.
* AJCC/UICC 9th edition stage IB-II untreated non-metastatic nasopharyngeal carcinoma (T3 requires no extensive cranial base invasion and the invasion volume should be \< 22 mL; N1-2 requires baseline lymph nodes \< 4 cm).
* Before treatment, plasma EBV-DNA needs to be tested and dynamic monitoring of EBV-DNA can be completed.
* ECOG performance status 0 - 1 points.
* Main organ functions meet the following requirements: neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN; creatinine clearance rate ≥ 60 mL/min.
* Sign a written informed consent form and be willing to complete the treatment, follow-up and quality of life assessment according to the protocol.
Exclusion Criteria:
* Metastasis to T4, N3 or distant sites; AJCC/UICC 9th edition stage III-IV.
* Had received chemotherapy, targeted therapy, or immunotherapy before the diagnosis of nasopharyngeal carcinoma, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).
* Pregnant or lactating; non-pregnant and non-lactating subjects who do not agree to take effective contraceptive measures.
* Had severe and uncontrollable heart, lung, liver, kidney, neurological or mental diseases, and the investigator judged that they were not suitable for radical treatment or affected compliance.
* Had a history of other malignant tumors within the past 5 years, except for the following situations: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc.
* Could not complete the imaging examinations, EBV-DNA tests, follow-up or quality of life assessment as required by the protocol.
Primary outcome measure(s)
2-year Locoregional Failure-Free Survival，2-y LRFFS — 2 year The time from enrollment to the first local or regional failure or any cause of death is determined by the event that occurs first. For those who did not experience any of these events, they are censored at the last valid follow-up date.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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