This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma
This study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma. Patients with resectable esophageal squamous cell carcinoma receive 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). Patients who do not progress with distant metastases start preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gy for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy irrespectively of objective response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
Fluorouracil is used in two cycles of neoadjuvant chemotherapy
Alexey Tryakin
Moscow, Russia
RECRUITINGRussian Cancer Research Center named after N.N.Blokhin RAMS
Moscow, Russia
RECRUITINGDisease free survival
Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.
Time frame: 24 months
Overall survival
Overall survival will be calculated from the start of the treatment to the death of any reason.
Time frame: 24 months
Objective response rate according to RECIST 1.1
Objective response rate will be evaluated separately after chemotherapy and chemoradiotherapy.
Time frame: 24 months
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Toxicity will be assessed separately after chemotherapy, chemoradiotherapy and surgery according NCI CTC AE 4.0
Time frame: 24 months
Pathological complete response rate following chemoradiotherapy
Pathological complete response rate following chemoradiotherapy will be assessed in resected patients
Time frame: 24 months
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Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.
Open Ivor Lewis esophagogastrectomy