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

RecruitingPhase 3Ages 18 Years - 75 YearsAllKrankenhaus Nordwest
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • 5-Fluorouracil
  • Leucovorin
  • Oxaliplatin
  • Docetaxel
  • Cisplatin
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Where

15 sites
Uniklinik RWTH Aachen, AöR, Medizinische Klinik III, Studienzentrum Viszeralmedizin
Aachen, Germany
Universitätsklinikum, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie
Dresden, Germany
Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
Frankfurt, Germany
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Viszerale, Gefäß- und Endokrine Chirurgie
Halle, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie
Leipzig, Germany
Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Pneumologie, Diabetologie und Infektiologie
Ludwigsburg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Chirurgie
Lübeck, Germany
Universitätsklinikum Magdeburg
Magdeburg, Germany

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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