This prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1:1 ratio to receive reduced-dose radiotherapy (60Gy/30F) alone or reduced-dose radiotherapy plus concurrent chemotherapy or standard dose radiotherapy (70Gy/33F) with concurrent chemotherapy. To solve the urgent problem of whether patients with high-risk advanced nasopharyngeal carcinoma are suitable for downgrade treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
504
Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy including GP, TP, and TPF regimen.
a) Camrelizumab 200mg, b) Toripalimab 240mg, or c) Adebrelimab 1200mg will be started on day 1 of induction chemotherapy and given every 3 weeks for up to 12 cycles, or until intolerable toxicity, or disease progression or withdrawal from the treatment.
GTVnx:60Gy/30F/2.0Gy,CTV1:54Gy/30F/1.8Gy,CTV2:48Gy/30F/1.6Gy
GTVnx:69.96Gy/33Fr/2.12Gy;CTV1:60.60Gy/33Fr/1.82y;CTV2:54.12Gy/33Fr/1.64Gy
Cisplatin 100mg/m2 every 3 weeks for 2 cycles
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgress-Free Survival (PFS)
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Time frame: 3 years
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Time frame: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Defined as the time from randomisation to the date of first locoregional relapse.
Time frame: 3 years
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomisation to the date of first distant metastases.
Time frame: 3 years
The proportion of patients with treatment related acute complications
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time frame: 1 year
The proportion of patients with treatment related late complications
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.
Time frame: 3 years
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