Actively Recruiting
HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)
Led by Krankenhaus Nordwest · Updated on 2024-11-12
200
Participants Needed
15
Research Sites
332 weeks
Total Duration
On this page
Sponsors
K
Krankenhaus Nordwest
Lead Sponsor
D
Deutsche Krebshilfe e.V., Bonn (Germany)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, randomized, controlled, open-label study evaluating efficacy and safety of perioperative FLOT chemotherapy plus intraoperative HIPEC versus FLOT chemotherapy alone in patients with resectable localized and locally advanced diffuse and mixed type adenocarcinoma of the stomach and Type II/III GEJ.
CONDITIONS
Official Title
HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed, operable, resectable diffuse or mixed type adenocarcinoma of gastroesophageal junction (AEG II-III) or stomach (uT3, uT4a, any N, M0) or any T N+ M0
- Received 3 to 6 cycles of neoadjuvant FLOT chemotherapy (dose modification allowed)
- No prior cytotoxic or targeted therapy except neoadjuvant FLOT
- No previous partial or complete tumor resection
- Age between 18 and 75 years; females with childbearing potential must have a negative pregnancy test within 7 days before study start
- Males and females of reproductive potential must agree to use highly effective contraception during study
- ECOG performance status 0 or 1
- No distant metastases by CT or MRI of abdomen, pelvis, thorax; no bone metastases by bone scan or MRI if suspected
- Laparoscopy excludes peritoneal carcinomatosis before starting FLOT chemotherapy
- Adequate blood, liver, and kidney function for surgery and HIPEC
- Able and willing to provide informed consent and comply with study and surgery procedures
You will not qualify if you...
- No neoadjuvant therapy or neoadjuvant therapy other than FLOT
- Known allergy to 5-FU, leucovorin, oxaliplatin, or docetaxel
- Other contraindications to 5-FU, leucovorin, oxaliplatin, or docetaxel
- Clinically significant active coronary heart disease, cardiomyopathy, or congestive heart failure (NYHA III-IV)
- Clinically significant heart valve defects
- Past or current other cancers not curatively treated or without disease-free period over 3 years (except treated basal cell carcinoma or in situ cervical carcinoma)
- Primary unresectability such as major blood vessel or adjacent organ invasion (T4b) or involved distant lymph nodes
- Severe internal disease or acute infection
- Major surgery within 28 days before enrollment
- Cirrhosis Child-Pugh B or worse, or cirrhosis with history of encephalopathy or ascites
- Participation in another interventional clinical study within 30 days before or during this study
- Pregnant or breastfeeding, or planning pregnancy
- Institutionalized by authority or court decision
- Any other concurrent anti-cancer treatment including radiation
- Known intraabdominal adhesions
- Pre-existing peritoneal seeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Uniklinik RWTH Aachen, AöR, Medizinische Klinik III, Studienzentrum Viszeralmedizin
Aachen, Germany, 52074
Actively Recruiting
2
Universitätsklinikum, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie
Dresden, Germany, 01307
Actively Recruiting
3
Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
Frankfurt, Germany, 60488
Actively Recruiting
4
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Viszerale, Gefäß- und Endokrine Chirurgie
Halle, Germany, 06120
Actively Recruiting
5
Universitätsklinikum Leipzig, Klinik und Poliklinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie
Leipzig, Germany, 04103
Actively Recruiting
6
Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Pneumologie, Diabetologie und Infektiologie
Ludwigsburg, Germany, 71640
Actively Recruiting
7
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Chirurgie
Lübeck, Germany, 23538
Actively Recruiting
8
Universitätsklinikum Magdeburg
Magdeburg, Germany, 39120
Actively Recruiting
9
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Innere Medizin III
München, Germany, 81675
Actively Recruiting
10
Universitätsklinikum Münster, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Münster, Germany, 48149
Actively Recruiting
11
Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
Regensburg, Germany, 93049
Actively Recruiting
12
Klinikum Südstadt Rostock, Klinik für Innere Medizin III
Rostock, Germany, 18059
Actively Recruiting
13
Universitätsklinikum Tübingen, Universitätsklinik für Allgemeine, Viszeral- und Transplantationschirurgie Chirurgische Studienzentrale
Tübingen, Germany, 72076
Actively Recruiting
14
Marien-Hospital Witten
Witten, Germany, 58452
Actively Recruiting
15
Universitätsklinikum Würzburg, Chirurgische Klinik I, Chirurgisches Studienzentrum
Würzburg, Germany, 97080
Actively Recruiting
Research Team
T
Thorsten O Götze, MD
CONTACT
C
Claudia Pauligk, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here