🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT04447352
Recruiting Phase 3

HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)

NCT04447352 · tracked via the Priya Life Science Germany tracker
Sponsor
Krankenhaus Nordwest
Phase
Phase 3
Started
2020-12-17
Last updated
2024-11-12

Condition(s) studied

Gastric CancerGastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

5-Fluorouracil →Leucovorin →Oxaliplatin →Docetaxel →Cisplatin →

5-Fluorouracil: Day 1 q2w: 2600 mg/m² IV over 24 hours

Leucovorin: Day 1 q2w: 200 mg/m² IV over 30 minutes

Oxaliplatin: Day 1 q2w: 85 mg/m² IV over 2 hours

Docetaxel: Day 1 q2w: 50 mg/m² IV over 1 hour

Cisplatin: intraoperative: 75mg/m² intraabdominal solution over 1 hour and 30 minutes

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Histologically confirmed, medically operable, resectable diffuse or mixed type (according to Lauren's classification) adenocarcinoma of the gastroesophageal junction (AEG II-III) or the stomach (uT3, uT4a, any N category, M0), or any T N+ M0 patient 2. Patient has received 3 to 6 cycles of neoadjuvant FLOT (de-escalation or dose modification allowed) 3. No preceding cytotoxic or targeted therapy other than neoadjuvant FLOT (including de-escalated or dose reduced schema) therapy 4. No prior partial or complete tumor resection 5. Female and male patient ≥ 18 and ≤ 75 years. Female patient with childbearing potential needs to have a negative pregnancy test within 7 days prior to study start. Males and females of reproductive potential must agree to practice highly effective contraceptive measures\* during the study. Male patients must also agree to refrain from father a child during treatment and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure. \*highly effective (i.e. failure rate of \<1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments). 6. ECOG ≤ 1 7. Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI 8. Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start of FLOT chemotherapy 9. Hematological, hepatic and renal function parameters adequate to allow surgical procedure and HIPEC at investigator´s discretion 10. Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures Exclusion Criteria: 1. Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT 2. Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel 3. Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel 4. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV 5. Clinically significant valvular defect 6. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 3 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix 7. Criteria of primary unresectability, e.g.: * Radiologically documented evidence of major blood vessel invasion or invasion of adjacent organs (T4b). * Patients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastases!) 8. Other severe internal disease or acute infection 9. Patient has undergone major surgery within 28 days prior to enrollment 10. Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites. 11. On-treatment participation in another interventional clinical study in the period 30 days prior to inclusion and during the study 12. Patient pregnant or breast feeding, or planning to become pregnant 13. Patient in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4) 14. Any other concurrent antineoplastic treatment including irradiation 15. Known intraabdominal adhesion situs 16. Pre-existing peritoneal seeding

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Uniklinik RWTH Aachen, AöR, Medizinische Klinik III, Studienzentrum Viszeralmedizin Aachen Germany Recruiting
Universitätsklinikum, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie Dresden Germany Recruiting
Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany Frankfurt Germany Recruiting
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Viszerale, Gefäß- und Endokrine Chirurgie Halle Germany Recruiting
Universitätsklinikum Leipzig, Klinik und Poliklinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie Leipzig Germany Recruiting
Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Pneumologie, Diabetologie und Infektiologie Ludwigsburg Germany Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Chirurgie Lübeck Germany Recruiting
Universitätsklinikum Magdeburg Magdeburg Germany Recruiting
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Innere Medizin III München Germany Recruiting
Universitätsklinikum Münster, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Münster Germany Recruiting
Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie Regensburg Germany Recruiting
Klinikum Südstadt Rostock, Klinik für Innere Medizin III Rostock Germany Recruiting
Universitätsklinikum Tübingen, Universitätsklinik für Allgemeine, Viszeral- und Transplantationschirurgie Chirurgische Studienzentrale Tübingen Germany Recruiting
Marien-Hospital Witten Witten Germany Recruiting
Universitätsklinikum Würzburg, Chirurgische Klinik I, Chirurgisches Studienzentrum Würzburg Germany Recruiting

More Krankenhaus Nordwest trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04447352 on ClinicalTrials.gov ↗ ← All trials in Germany