The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.
Induction chemotherapy combined with immunotherapy has shown promising efficacy in locally advanced head and neck cancers. However, the appropriate dose and range of the following radical radiotherapy treatment remains unknown. Eligibility patients were assigned to three arms depending on the degree of clinical remission: clinical complete response (radiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance), deep partial response (radiotherapy 66Gy + concurrent chemotherapy + immunotherapy maintenance, non-deep partial response (radiotherapy 70Gy + concurrent chemotherapy + immunotherapy maintenance). Progression-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
concurrent chemoradiotherapy (60Gy) after induction therapy
concurrent chemoradiotherapy (66Gy) after induction therapy
concurrent chemoradiotherapy (70Gy) after induction therapy
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Beijing, China
RECRUITINGProgression-free survival
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment
Time frame: 2 years
Overall survival
defined as the time from random assignment to death from any cause or censored at the date of last follow-up
Time frame: 2 years
Deep partial response
Defined as maximum tumor diameter retreat ≥ 50%
Time frame: 2 years
Local-Regional failure survival
defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment
Time frame: 2 years
Toxicity Adverse events
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) and late radiation toxicities were assessed by NCI-CTCAE v5.0
Time frame: 2 years
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immunotherapy maintenance with anti-PD-1 or PDL1antibody every three weeks for 1 year after radiotherapy