The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer
NCT ID: NCT02976142
Last Updated: 2016-12-13
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
150 participants
INTERVENTIONAL
2016-12-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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neoadjuvant chemoimmunotherapy
Patients with gastric cancer and verified free cancer cells who receive 1 course of intraperitoneal immunotherapy with interleykin-2 + 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -\> M0) surgical treatment will be performed.
neoadjuvant chemoimmunotherapy
neoadjuvant chemotherapy
Patients with gastric cancer and verified free cancer cells who receive 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -\> M0) surgical treatment will be performed.
No interventions assigned to this group
Interventions
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neoadjuvant chemoimmunotherapy
Eligibility Criteria
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Inclusion Criteria
* Histologically proven gastric cancer T2-3 N+, T4a with any N (0,+) with free cancer cells in the abdominal cavity and no macroscopic canceromathosis and no other distant metastases (TNM classification 7th edition)
* Histological forms: gastric adenocarcinoma and signet ring cancer
* Blood characteristics (creatinine \<150 mg/l, total bilirubin \< 50 mkmol/l, neutrophils \< 1500/mkl, hemoglobin \>90 g/l, thrombocytes \> 100000/mkl)
Exclusion Criteria
* Synchronic or metachronic malignant tumors
* Previous systemic or surgical or combined therapy for gastric cancer
* Complications of gastric cancer (obstruction 0-1 GOOSS scale and/or gastric bleeding)
* Adhesions in abdominal cavity
* Gastrooesophageal junction cancer or gastric cancer with spreading on oesophagus.
18 Years
80 Years
ALL
No
Sponsors
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Moscow Clinical Scientific Center
OTHER
Responsible Party
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Principal Investigators
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Nikolay Semenov
Role: PRINCIPAL_INVESTIGATOR
Moscow Clinical Scientific Center
Boris Pomortsev
Role: PRINCIPAL_INVESTIGATOR
Moscow Clinical Scientific Center
Central Contacts
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Other Identifiers
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MKNC02/2016
Identifier Type: -
Identifier Source: org_study_id