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

December 12, 2016 updated by: Moscow Clinical Scientific Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: neoadjuvant chemoimmunotherapy
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall 2-year survival
Time Frame: 2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Portability of the systemic therapy methods
Time Frame: 6,9,12,24 months
Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale.
6,9,12,24 months
Mortality
Time Frame: 24 months
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.
24 months
Downstaging tumor
Time Frame: 2 years
Number of patients that were downstaged (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.
2 years
Morbidity
Time Frame: 30 days
Number of postoperative morbidity and mortality in the early post-operative period (for patients who received radical (R0) surgical treatment after downstaging)
30 days
Quality of life
Time Frame: 6, 12, 18, 24 months
Quality of life ECOG scale.
6, 12, 18, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow Clinical Scientific Center

Investigators

  • Principal Investigator: Nikolay Semenov, Moscow Clinical Scientific Center
  • Principal Investigator: Boris Pomortsev, Moscow Clinical Scientific Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKNC02/2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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