Clinical trial: Chemotherapy Alone vs. Chemotherapy + Surgical Resection in Patients With Limited-metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction (NCT02578368)

Eligibility criteria:
Inclusion Criteria:

          1. Histologically confirmed limited metastatic gastric or GEJ adenocarcinoma.*

          2. Medical and technical operability of the primary.

          3. Metastatic lesions are resectable or can be controlled by local ablative procedure
             (central evaluation).

          4. No prior chemotherapy and no prior tumor resection.

          5. Female and male patients ≥ 18 years. Patients in reproductive age must be willing to
             use adequate contraception during the study and 3 months after the end of the study
             (appropriate contraception is defined as surgical sterilization (e.g., bilateral tubal
             ligation, vasectomy), hormonal contraception (implantable, patch, oral), and
             double-barrier methods (any double combination of: intrauterine device, male or female
             condom with spermicidal gel, diaphragm, sponge, cervical cap)). Female patients with
             childbearing potential need to have a negative pregnancy test within 7 days before
             study start.

          6. ECOG (Eastern Cooperative Oncology Group) Performance Status 0 or 1

          7. Adequate hematological, hepatic and renal function parameters:

               -  Leukocytes ≥ 3000/µl

               -  Platelets ≥ 100,000/µl

               -  Serum creatinine ≤ 1.5 x upper limit of normal, or glomerular filtration rate
                  (GFR) > 40 ml/min

               -  Bilirubin ≤ 1.5 x upper limit of normal

               -  AST (aspartate aminotransferase) and ALT (alanine transaminase) ≤ 3.5 x upper
                  limit of normal

               -  Alkaline phosphatase ≤ 6 x upper limit of normal

          8. Written informed consent of the patient.

        (*) Definition of the limited metastatic status is:

          1. Retroperitoneal lymph node metastases (RPLM) (e.g., para-aortal, intra-aorto-caval,
             parapancreatic or mesenterial lymph nodes) only (Note: in duodenum invading gastric
             cancer, retropancreatic nodes are not regarded M1) or/and

          2. at maximum one organ involved with or without RPLM according to the following schema:
             I. Localized potentially operable peritoneal carcinomatosis: stage P1 according to
             classification of the "Japanese Research Society for Gastric Cancer" (Clinically
             visible carcinomatosis of the peritoneum or of the pleura and >P1 peritoneal
             carcinomatosis are not allowed!) or II. Liver: maximum of 5 metastatic lesions that
             are potentially resectable or III. Lung: unilateral involvement, potentially
             resectable or IV. Uni- or bilateral Krukenberg tumors (ovarian met.) in the absence of
             macroscopic peritoneal carcinomatosis or V. Uni- or bilateral adrenal gland metastases
             or VI. Extra-abdominal lymph node metastases such as supraclavicular or cervical lymph
             node involvement or VII. Localized bone involvement (defined as being within one
             radiation field) or VIII. Other metastatic disease location that is considered limited
             by the investigator and is confirmed by the review committee

        Exclusion Criteria:

          1. Medical inoperability

          2. Inability to understand the aims of the study and/or protocol procedures

          3. Metastatic disease not fulfilling the criteria of limited disease mentioned in the
             inclusion criteria or non-metastatic stage (cM0)

          4. Cirrhosis of the liver, pronounced alcohol abuse with anticipated detoxification,
             severe pulmonary infection with considerable reduction of pulmonary function

          5. Primary not resectable

          6. Hypersensitivity to 5-fluorouracil, leucovorin, oxaliplatin, docetaxel, or trastuzumab
             (in HER-2 positive tumors)

          7. Contraindication versus 5-fluorouracil, leucovorin, oxaliplatin, docetaxel (see
             specific product information), or trastuzumab (in HER-2 positive tumors)

          8. Clinically significant active coronary heart disease, cardiomyopathy or congestive
             heart failure, NYHA (New York Heart Association) III-IV

          9. Clinically significant valvular defect

         10. Past or current history of other malignancies unless 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

         11. Known brain metastases

         12. Other severe internal disease or acute infection

         13. Peripheral polyneuropathy > NCI grade II

         14. Serious hepatic impairment (AST/ALT>3.5xULN, AP>6xULN, bilirubin>1.5xULN; ULN = upper
             limit of normal)

         15. Chronic inflammatory bowel disease

         16. Any other concurrent antineoplastic treatment including irradiation

         17. Participation in another clinical study

         18. Pregnancy or lactation
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.


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? 1