This is a prospective single-arm study of endoscopic resection (ER) following concurrent chemoradiotherapy for stage I esophageal squamous cell carcinoma, to find if the treatment combination is useful by assessing its safety and efficacy.
The objectives are to evaluate the efficacy and safety of concurrent chemoradiotherapy after endoscopic resection in early stage esophageal squamous cell carcinoma by evaluating the effectiveness, including 3-year OS, DFS, LRFS, DMFS, LCR, DMR and QOF, and analyzing the toxicity and side effects in 3 years follow-up time. The study preliminarily explored the recurrence patterns of solely ER for early esophageal squamous cell carcinoma with high risk factors, analyzed the rationality of target areas and dose choices in the treatment regimen of concurrent chemoradiotherapy after ER, and proposed modification schemes of the target area and dose of radiotherapy. Prospectively acquired hematological samples and tissue samples during the treatment will be tested for genetic testing, single-cell genome sequencing, transcriptome and epigenomic analysis, to screen the population with high risk of recurrence or the population who will benefit from this treatment combination. In terms of sample size, The estimates of survival rate at 3 years for operation group is 85.1% (95% CI: 82.0%, 87.7%) based on SEER study. Assuming that the survival rate at 3 years for ER+CRT is about 90.7%. The difference between operation and ER+CRT is marginal and clinically meaningless. In our study, we will target to establish that the ER+CRT is non-inferiority to operation in term of survival rate at 3 years, and further investigate the benefit of ER+CRT in safety profile and quality of life. A non-inferiority margin 10% is applied with respect to 85.1%. A number of 50 subjects is adequate to achieve 80% statistical power under a type one error rate 0.025 one-sided. The power analysis is based on simulation, 10000 iterations are carried out, Greenwood's method is applied.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Intensity-modulated radiation therapy (IMRT) with a total dose of 45Gy in 25 fractions
Nedaplatin 25 mg/m2 and Paclitaxel liposome 45mg/m2, day 1, every week, 5 weeks
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
RECRUITINGOverall survival (OS)
OS was defined as the time from endoscopic resection to the last follow-up time or death due to any cause.
Time frame: 3-year
Adverse events (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Time frame: 3-year
Disease Free Survival (DFS)
DFS was defined as the time from the date of endoscopic resection to the date of tumor recurrence as assessed by RECIST 1.1, the last follow-up or death.
Time frame: 3-year
Local Recurrence Free Survival (LRFS)
LRFS was defined as the time from the date of endoscopic resection to the date of local recurrence (Local recurrence: documented evidence of newly found lesions at the primary surgical site and 1 cm around) as assessed by RECIST 1.1, the last follow-up or death.
Time frame: 3-year
Disease Metastasis Free Survival (DMFS)
DMFS was defined as the time from the date of endoscopic resection to the date of tumor metastasis as assessed by RECIST 1.1, the last follow-up or death.
Time frame: 3-year
Local Control Rate (LCR)
LCR was defined as percentage of participants who did not have local recurrence as assessed by RECIST 1.1 from the date of endoscopic resection to the date of the last follow-up or death.
Time frame: 3-year
Distant Metastasis Rate (DMR)
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DMR was defined as percentage of participants who had tumor distant metastasis as assessed by RECIST 1.1 from the date of endoscopic resection to the date of the last follow-up or death.
Time frame: 3-year
Quality of Life (QOL): questionnaires
Evaluate the quality of life via questionnaires
Time frame: 3-year