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New treatment option for Gastric Cancer
Official title HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)
ClinicalTrials.gov ID: NCT04447352
What this study is testing
What is 5-Fluorouracil?
5-Fluorouracil is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for gastric cancer.
Also referred to as 5-FU.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically confirmed, medically operable, resectable diffuse or mixed type (according to Lauren's classification) adenocarcinoma of the...
- 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...
You likely can't join if
- Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT
- Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel
- Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel
- Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
- Clinically significant valvular defect
- Past or current history of other malignancies not curatively treated and without evidence of disease for more than 3 years, except for curatively...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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
- Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT
- Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel
- Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel
- Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
- Clinically significant valvular defect
- 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...
- 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!)
- Other severe internal disease or acute infection
- Patient has undergone major surgery within 28 days prior to enrollment
- Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites.
- On-treatment participation in another treatment clinical study in the period 30 days prior to inclusion and during the study
- Patient pregnant or breast feeding, or planning to become pregnant
- Patient in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)
- Any other concurrent antineoplastic treatment including irradiation
- Known intraabdominal adhesion situs
- Pre-existing peritoneal seeding
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, Germany
- Dresden, Germany
- Frankfurt, Germany
- Halle, Germany
- Leipzig, Germany
- Ludwigsburg, Germany
- Lübeck, Germany
- Magdeburg, Germany
- München, Germany
- Münster, Germany
- Regensburg, Germany
- Rostock, Germany
- Tübingen, Germany
- Witten, Germany
- Würzburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, Germany; Dresden, Germany; Frankfurt, Germany; Halle, Germany; Leipzig, Germany; Ludwigsburg, Germany and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.