Trials Sponsors Conditions Drugs Pricing

Conditions

Gastric Neoplasms

Outcome Measures

Primary Outcomes (1)

Incidence of peritoneal metastases and proportion of patients free from peritoneal metastasis after one year after HIPEC.
The primary objective of the study is to estimate the effect of a combined therapy with gastrectomy and HIPEC in localized advanced gastric cancer. The primary target is the incidence of peritoneal metastases in CT and the proportion of patients who after one year are free from peritoneal metastasis. The study is intended to provide planning data for a subsequent Phase III study in the form of an RCT.
one year

Secondary Outcomes (3)

Overall Survival (OS)
one year
Progression-free survival (PFS)
one year
Number of participants with treatment-related adverse events as assessed by grading according to CTCAE v5.0 and Clavien-Dindo.
one year

Study Arms (1)

HIPEC-Treatment

EXPERIMENTAL

Doxorubicin (15 mg/m²/body surface) Cisplatin (75 mg/m²/body surface) applied as hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy. All drugs used are approved.

Drug: intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)

Interventions

intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)Drug

single dose application of hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy

HIPEC-Treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent of the patient
Positive lavage cytology in staging laparoscopy

Sponsors & Collaborators

University Hospital Tuebingen
Otherlead

Study Sites (1)

University Department of General, Visceral and Transplant Surgery

Tübingen, Baden-Wurttemberg, 72076, Germany

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 29, 2019

Study Start

November 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

HIPEC-Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

HIPEC-Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations