Neoadjuvant Chemotherapy Followed by Preoperative Chemoradiation in Resectable Squamous-cell Esophageal Cancer
NCT ID: NCT03579004
Last Updated: 2018-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
48 participants
INTERVENTIONAL
2017-07-10
2020-07-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trimodality approach
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
Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
Cisplatin
Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
Fluorouracil
Fluorouracil is used in two cycles of neoadjuvant chemotherapy
chemoradiotherapy
Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.
Ivor Lewis esophagogastrectomy
Open Ivor Lewis esophagogastrectomy
Interventions
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Paclitaxel
Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
Cisplatin
Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
Fluorouracil
Fluorouracil is used in two cycles of neoadjuvant chemotherapy
chemoradiotherapy
Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.
Ivor Lewis esophagogastrectomy
Open Ivor Lewis esophagogastrectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed resectable squamous-cell Tumor (T)1-2 node (N)+, T3N0-3 esophageal cancer. Inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed
3. No prior antineoplastic treatment
4. Eastern Cooperative Oncology Group (ECOG) status 0-2
5. Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy
* absolute neutrophil count ≥ 1,500 х109/l
* thrombocytes ≥ 100 х 109/l
* hemoglobin ≥ 90 mg/l
* creatinine \< 115 µmol/л or creatinine clearance ≥ 55 ml/min
* alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN)
* alkaline phosphatase (ALP) \> 5 x ULN
* bilirubin \> 1,5 х ULN
6. Women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment
7. Patients must follow appropriate contraception rules during whole treatment period
8. Decrease of body weight must not be more than 20% in last 6 months
Exclusion Criteria
2. Bulky (\>3 cm) regional lymphnodes metastases;
3. Cervical esophageal cancer;
4. Presence of tumor fistula;
5. Prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer;
6. Active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;
18 Years
75 Years
ALL
No
Sponsors
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Mona Frolova
OTHER
Responsible Party
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Mona Frolova
Senior Staff Member
Principal Investigators
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Alexey Tryakin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
N.N.Blokhin Russian Cancer Research Center
Locations
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Alexey Tryakin
Moscow, , Russia
Russian Cancer Research Center named after N.N.Blokhin RAMS
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-038
Identifier Type: -
Identifier Source: org_study_id
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