Neoplasms

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Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

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Neoplasms, Squamous Cell

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Esophageal Cancer

Antineoplastic Agents

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Paclitaxel

Fluorouracil

Albumin-Bound Paclitaxel

Cisplatin

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Immunologic Factors

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). 3-4 weeks later - preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 Gray (Gy) for 4 weeks).

4-6 weeks after completion of chemoradiation patients undergo Ivor Lewis esophagogastrectomy.

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

Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.

chemoradiotherapy

Ivor Lewis esophagogastrectomy

Alexey Tryakin, MD, PhD

Ilya Pokataev, MD, PhD

Alexey Tryakin, PhD

Ilya Pokataev

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.

Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer

Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer: Single Arm Phase II Study

Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.

Overall survival will be calculated from the start of the treatment to the death of any reason.

Objective response rate will be evaluated separately after chemotherapy and chemoradiotherapy.

Toxicity will be assessed separately after chemotherapy, chemoradiotherapy and surgery according NCI CTC AE 4.0

Pathological complete response rate following chemoradiotherapy will be assessed in resected patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer	NCT03579004	Esophageal Neop... Squamous Cell C... Concurrent Chem...	Paclitaxel Cisplatin Fluorouracil chemoradiothera... Ivor Lewis esop...	18 Years - 75 Years	Russian Academy of Medical Sciences
Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer	NCT03579004	Esophageal Neop... Squamous Cell C... Concurrent Chem...	Paclitaxel Cisplatin Fluorouracil chemoradiothera... Ivor Lewis esop...	18 Years - 75 Years	Russian Academy of Medical Sciences

Spots Global Cancer Trial Database for ivor lewis esophagogastrectomy