About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
reduced dose group
Radiation59.4 Gy/27F
Standard Dose Group
Radiation66 Gy/30F
concurrent chemoradiotherapy
Other intervention66.0-70.4 Gy/30-32F + cisplatin 80 mg/m² q3w×2
Treatment groups
Trial outcomes
Primary outcomes
2-year Locoregional Failure-Free Survival,2-y LRFFS
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.
Secondary outcomes
2-year Failure-Free Survival,2-y FFS
The time from enrollment to the first occurrence of local regional failure, distant metastasis, or death due to any cause is determined by the event that occurs first.
2-year Overall Survival,2-y OS
The time from enrollment to any cause of death; for those who were still alive at the end of the follow-up, the data are censored at the date of the last confirmed survival.
2-year Distant Failure-Free Survival,2-y DFFS
The time from enrollment to the first distant metastasis or any cause of death is determined by the event that occurs first.
Acute Adverse Events,acute AEs
The evaluation was conducted according to NCI-CTCAE v5.0 from the start of radiotherapy to 90 days after radiotherapy.
Sponsors and contacts
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