RecruitingPhase 3NCT04447352
HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)
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
Sponsor
Krankenhaus Nordwest
Enrollment
200 participants
Start Date
Dec 17, 2020
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria11
- 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
Exclusion Criteria18
- 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 cervix
- 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 interventional 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
Interventions
DRUG5-Fluorouracil
Day 1 q2w: 2600 mg/m² IV over 24 hours
DRUGLeucovorin
Day 1 q2w: 200 mg/m² IV over 30 minutes
DRUGOxaliplatin
Day 1 q2w: 85 mg/m² IV over 2 hours
DRUGDocetaxel
Day 1 q2w: 50 mg/m² IV over 1 hour
DRUGCisplatin
intraoperative: 75mg/m² intraabdominal solution over 1 hour and 30 minutes
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT04447352
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