The objective of this study is to evaluate the efficacy of neoadjuvant stereotactic body radiation therapy (SBRT) in combination with chemotherapy and immunotherapy, prior to radical surgery, in enhancing the 2-year event-free survival rate and overall survival rate in patients diagnosed with locally advanced oral or HPV-unrelated oropharyngeal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
The patient was initially subjected to a neoadjuvant treatment regime, encompassing stereotactic body radiotherapy (SBRT) and chemoimmunotherapy. The SBRT was administered with a dose of 6 Gy per fraction to the primary tumour and metastatic lymph nodes, administered every other day for a total of three fractions. Following this, a period of one to two weeks was to elapse before the initiation of Tislelizumab (200 mg), Docetaxel (75 mg/m²), and Cisplatin (75 mg/m²), on a three-week cycle, for a total of two cycles. A subsequent imaging re-examination was to be performed for assessment two weeks after the final chemotherapy cycle. Finally, curative surgical resection was to be performed 3-4 weeks after the final chemotherapy cycle, followed by adjuvant postoperative radiotherapy or chemoradiotherapy with cisplatin at a dose of 100 mg/m² for two cycles.
Radical surgery followed by postoperative radiotherapy or chemoradiotherapy with cisplatin at a dose of 100 mg/m² for three cycles.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
2-year event-free survival
The time interval from randomization to the occurrence of imaging tumor progression during the neoadjuvant treatment stage that makes surgery impossible, or postoperative imaging or biopsy results show local tumor recurrence, lymph node recurrence, distant metastasis, or death for any cause.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to two years.
2-year overall survival
The time interval from random start to death for any cause.
Time frame: From date of randomization until the date of death from any cause, assessed up to two years.
MPR
Proportion of patients with ≤10% viable tumor cells identified per AJCC/CAP Tumor Regression Grading (TRG) protocol evaluation of surgical specimens.
Time frame: Three weeks after surgery
pCR
Proportion of patients with no viable tumor cells identified upon complete and systematic evaluation of postoperative specimens under the AJCC/CAP Tumor Regression Grading (TRG) protocol, including microscopic examination of all sampled primary tumor sites and regional lymph nodes.
Time frame: Three weeks after surgery
Mandibular Preservation Rate
Proportion of oral cancer patients retaining mandibular continuity after primary tumor resection.
Time frame: On the day of surgery
Incidence rates of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Percentage of patients with adverse events ≥ Grade 3 among all treated patients.
Time frame: Through study completion, an average of 3 year
Quality of life assessment
Quality of life was assessed using the EORTC QLQ-C30 scale at postoperative time point of 2 year.
Time frame: Postoperatively at 24 months
Quality of life assessment
Quality of life was assessed using the QLQ-H\&N35 scale at postoperative time point of 2 year
Time frame: Postoperatively at 24 months
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