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The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer

Primary Purpose

Gastric Cancer, Metastatic

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
neoadjuvant chemoimmunotherapy
Sponsored by
Moscow Clinical Scientific Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer, Metastatic focused on measuring gastric cancer, metastatic, positive wash cytology, neoadjuvant intraperitoneal immunotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ECOG 0-2
  • 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:

  • Clinically apparent distant metastasis (besides free cancer cells)
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    neoadjuvant chemoimmunotherapy

    neoadjuvant chemotherapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Overall 2-year survival
    Overall 2-year survival for patients who received radical (R0) surgical treatment after downstaging (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.

    Secondary Outcome Measures

    Portability of the systemic therapy methods
    Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale.
    Mortality
    Mortality related to intraperitoneal immunotherapy and systemic chemotherapy It is defined as the death within 24 months from the start of the treatment regardless of the reason.
    Downstaging tumor
    Number of patients that were downstaged (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.
    Morbidity
    Number of postoperative morbidity and mortality in the early post-operative period (for patients who received radical (R0) surgical treatment after downstaging)
    Quality of life
    Quality of life ECOG scale.

    Full Information

    First Posted
    November 24, 2016
    Last Updated
    December 12, 2016
    Sponsor
    Moscow Clinical Scientific Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02976142
    Brief Title
    The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer
    Official Title
    Prospective Randomized Phase II Clinical Trial: the Efficacy of Surgical Treatment in Combinations With Intraperitoneal Immunotherapy and Systemic Chemotherapy in Patients With Gastric Cancer and Verified Free Cancer Cells
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Moscow Clinical Scientific Center

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether intraperitoneal immunotherapy (with interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more effective than systemic chemotherapy alone in patients with gastric cancer and verified free cancer cells in abdominal cavity in improving the long term outcomes and overall survival of further surgical treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer, Metastatic
    Keywords
    gastric cancer, metastatic, positive wash cytology, neoadjuvant intraperitoneal immunotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    neoadjuvant chemoimmunotherapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    neoadjuvant chemotherapy
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    neoadjuvant chemoimmunotherapy
    Primary Outcome Measure Information:
    Title
    Overall 2-year survival
    Description
    Overall 2-year survival for patients who received radical (R0) surgical treatment after downstaging (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Portability of the systemic therapy methods
    Description
    Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale.
    Time Frame
    6,9,12,24 months
    Title
    Mortality
    Description
    Mortality related to intraperitoneal immunotherapy and systemic chemotherapy It is defined as the death within 24 months from the start of the treatment regardless of the reason.
    Time Frame
    24 months
    Title
    Downstaging tumor
    Description
    Number of patients that were downstaged (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.
    Time Frame
    2 years
    Title
    Morbidity
    Description
    Number of postoperative morbidity and mortality in the early post-operative period (for patients who received radical (R0) surgical treatment after downstaging)
    Time Frame
    30 days
    Title
    Quality of life
    Description
    Quality of life ECOG scale.
    Time Frame
    6, 12, 18, 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ECOG 0-2 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: Clinically apparent distant metastasis (besides free cancer cells) 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Igor Khatkov, Professor, PhD
    Email
    i.hatkov@mknc.ru
    First Name & Middle Initial & Last Name or Official Title & Degree
    Roman Izrailov, Professor, PhD
    Email
    r.izrailov@mknc.ru
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nikolay Semenov
    Organizational Affiliation
    Moscow Clinical Scientific Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Boris Pomortsev
    Organizational Affiliation
    Moscow Clinical Scientific Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer

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