Clinical trial: HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT) (NCT04447352)

Eligibility criteria:
Inclusion Criteria:

          1. Histologically confirmed, medically operable, resectable diffuse or mixed type (Lauren
             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. Adequate hematological, hepatic and renal function parameters:

               1. Leukocytes ≥ 3000/mm³, platelets ≥ 100,000/mm³, neutrophil count (ANC) ≥1000/µL

               2. Serum creatinine ≤ 1.5 x upper limit of normal

               3. Bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 3.0 x upper limit of
                  normal, alkaline phosphatase ≤ 6 x upper limit of normal

               4. For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN;
                  for patients receiving therapeutic anticoagulation: stable anticoagulant regimen

         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 5 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. Peripheral polyneuropathy ≥ NCI Grade II

         10. Patient has undergone major surgery within 28 days prior to enrollment except staging
             laparoscopy.

         11. Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a
             history of hepatic encephalopathy or ascites.

         12. On-treatment participation in another interventional clinical study in the period 30
             days prior to inclusion and during the study

         13. Patient pregnant or breast feeding, or planning to become pregnant

         14. Patient in a closed institution according to an authority or court decision (AMG § 40,
             Abs. 1 No. 4)

         15. Any other concurrent antineoplastic treatment including irradiation

         16. Known intraabdominal adhesion situs

         17. Pre-existing peritoneal seeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment