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).
This study focused on patients with AJCC/UICC 9th edition stage IB-II（The participants were required to have no extensive skull base invasion and lymph nodes \< 4 cm before treatment）. It aimed to adaptively guide the reduction of radiation dose for nasopharyngeal carcinoma based on the response to induction chemotherapy, thereby minimizing radiation-related toxicity while ensuring local control. Cohort 1 was randomly assigned 1:1 to the 59.4 Gy/27 fractions group and the 66.0 Gy/30 fractions group and compared their LRFFS. The participants were required to have EBV-DNA = 0 and CR or PR \> 50% after 2 courses of induction therapy. Those who did not meet the criteria were assigned to Cohort 2 to receive standard-dose radiotherapy combined with concurrent cisplatin to avoid excessive reduction of intensity for potentially high-risk patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
269
59.4 Gy/27F
66 Gy/30F
66.0-70.4 Gy/30-32F + cisplatin 80 mg/m² q3w×2
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
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.
Time frame: 2 year
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.
Time frame: 2 year
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.
Time frame: 2 year
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.
Time frame: 2 year
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.
Time frame: up to 90 days after radiotherapy
Late Adverse Events，late AEs
After 90 days of radiotherapy, the evaluation was conducted according to CTCAE v5.0 and RTOG/EORTC standards for late radiation injury.
Time frame: After 90 days of radiotherapy to the date of death，assessed up to 2 years or more.
Quality of Life，QoL (EORTC QLQ-H&N35）
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Changes in QoL of participants from baseline to up to 6 months after the completion of radiotherapy. QoL will be evaluated with the questionnaires of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30). Higher scores mean a worse outcome.
Time frame: baseline and up to one year