MOU-2017-01

Phase 1

• Conditions: locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I – III) with T3N0, T4N0, T2 – T4N+, stage Ib – IIIc; MedDRA version: 21.0Level: PTClassification code 10030137Term: Oesophageal adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001264-38-SK
• Lead Sponsor: Masarykuv onkologický ústav

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-19
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Age of 18 years or more
2.Not currently participating in another study
3.Able and willing to sign informed consent and to comply with study procedures
4.Biopsy-proven locally advanced resectable oesophago-gastric adenocarcinoma (Siewert I – III) with T3N0, T4N0, T2 – T4N+, stage Ib – IIIc I.Adenocarcinoma of distal part of the oesophagus II.Adenocarcinoma of the real cardia III.Adenocarcinoma of the subcardial stomach
5.Staging procedures include endoscopy, endoscopic ultrasound and FDG-PET
6.Eligible patients have to be fit for platinum-containing chemotherapy
7.Tumours must be potentially R0 resectable tumours during consecutive operation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Participation in another clinical trial of a therapeutic drug during the past 14 days
2.Addiction to alcohol or drugs
3.Women of child-bearing potential who are not using a commonly accepted effective means of contraception; women of child-bearing potential will have negative blood pregnancy test before enrollment
4.Pregnant women and nursing mothers are not allowed to enroll on this study
5.Eastern Cooperative Oncology Group score >2
6.Previous or secondary malignancy in past 5 years (Excluding skin cancer and early cervical carcinoma)
7.Life expectancy of less than 3 months
8.Uncontrolled bleeding from the tumour
9.Uncontrolled diabetes
10.Patients are also ineligible if they have undergone previous chemotherapy, radiotherapy, or endoscopic laser therapy for EGJ

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified