Preventive HIPEC in Combination With Perioperative FLOT Versus FLOT Alone for Resectable Diffuse Type Gastric and Gastroesophageal Junction Type II/III Adenocarcinoma - The Phase III PREVENT Trial of the AIO /CAOGI /ACO

Who is this study for? Adult patients with gastric or gastroesophageal junction adenocarcinoma
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

• Patient has received 3 to 6 cycles of neoadjuvant FLOT (de-escalation or dose modification allowed)

• No preceding cytotoxic or targeted therapy other than neoadjuvant FLOT (including de-escalated or dose reduced schema) therapy

• No prior partial or complete tumor resection

• 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).

• ECOG ≤ 1

• 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

• Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start of FLOT chemotherapy

• Hematological, hepatic and renal function parameters adequate to allow surgical procedure and HIPEC at investigator´s discretion

⁃ Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures

Locations
Other Locations
Germany
Uniklinik RWTH Aachen, AöR, Medizinische Klinik III, Studienzentrum Viszeralmedizin
RECRUITING
Aachen
Universitätsklinikum, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie
RECRUITING
Dresden
Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
RECRUITING
Frankfurt
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Viszerale, Gefäß- und Endokrine Chirurgie
RECRUITING
Halle
Universitätsklinikum Leipzig, Klinik und Poliklinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie
RECRUITING
Leipzig
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Chirurgie
RECRUITING
Lübeck
Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Pneumologie, Diabetologie und Infektiologie
RECRUITING
Ludwigsburg
Universitätsklinikum Magdeburg
RECRUITING
Magdeburg
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Innere Medizin III
RECRUITING
München
Universitätsklinikum Münster, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
RECRUITING
Münster
Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie
RECRUITING
Regensburg
Klinikum Südstadt Rostock, Klinik für Innere Medizin III
RECRUITING
Rostock
Universitätsklinikum Tübingen, Universitätsklinik für Allgemeine, Viszeral- und Transplantationschirurgie Chirurgische Studienzentrale
RECRUITING
Tübingen
Marien-Hospital Witten
RECRUITING
Witten
Universitätsklinikum Würzburg, Chirurgische Klinik I, Chirurgisches Studienzentrum
RECRUITING
Würzburg
Contact Information
Primary
Thorsten O Götze, MD
goetze.thorsten@khnw.de
+4969 7601
Backup
Claudia Pauligk, PhD
pauligk.claudia@khnw.de
+4969 7601
Time Frame
Start Date: 2020-12-17
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 200
Treatments
Active_comparator: Arm A - FLOT
Patients randomized to treatment Arm A already received 3-6 cycles of FLOT in 2-week treatment cycles prior to undergoing surgery. Following surgery, patients will receive four further 2-week cycles FLOT. FLOT can be deescalated to FLO, FLT or FL in case of chemorelated toxicity at any time and at the discretion of investigator.~FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m².
Experimental: Arm B - FLOT/HIPEC
Patients randomized to treatment Arm B already received 3-6 cycles of FLOT in 2-week treatment cycles prior to undergoing surgery including Intraoperative Hyperthermic IntraPEritoneal Chemoperfusion (HIPEC) during gastric-/ esophagogastric resection using Cisplatin 75mg/m². Following surgery, patients will receive four further 2-week cycles FLOT. FLOT can be deescalated to FLO, FLT or FL in case of chemorelated toxicity at any time and at the discretion of investigator.~FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m².
Related Therapeutic Areas
Sponsors
Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)
Leads: Krankenhaus Nordwest

This content was sourced from clinicaltrials.gov

Similar Clinical Trials