Clinical trial: Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology (NCT03092518)

Eligibility criteria:
-  INCLUSION CRITERIA:

          -  Patients must have histologically or cytologically confirmed gastric adenocarcinoma or
             gastroesophageal junction (Siewert I-III) adenocarcinoma confirmed by the Laboratory
             of Pathology, NCI

          -  Must have received systemic chemotherapy, minimum 3 months or maximum 6 months, prior
             to enrollment

          -  Systemic therapy should consist of at least fluoropyrimidine-based and/or platinum
             based chemotherapy

          -  Trastuzumab may be added for HER2-neu over-expressing cancers as clinically indicated

          -  Last dose of chemotherapy within 8 weeks of enrollment with recovery to Grade 1 from
             chemotherapy-related toxicities

          -  Documentation of chemotherapy administration must be obtained

          -  Subradiographic and/or cytopathologic evidence of peritoneal carcinomatosis found at
             staging laparoscopy.

          -  Documentation of cytopathologic diagnosis of malignant peritoneal cytology in the
             absence of disseminated peritoneal disease must be obtained. If cytologic analysis
             reveals atypical cells of undetermined significance, a repeat lavage with
             cytopathologic analysis will be performed and must demonstrate evidence of malignancy.

          -  Limited peritoneal involvement found at staging laparoscopy or on final pathology that
             is deemed completely resectable is permitted

          -  Age >18 years.

          -  ECOG performance status <2

          -  Patients must have normal organ and marrow function as defined below:

        hemoglobin > 8.0 g/dL

        absolute neutrophil count greater than or equal to 1,000/mcL

        platelets greater than or equal to100,000/mcL

        total bilirubin within normal institutional limits

        AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal

        creatinine < 1.5 mg/dl

        eGFR (creatinine clearance) greater than or equal to 60 mL/min/1.73 m2.

          -  Physiologically able to undergo HIPEC and gastrectomy

          -  No history of malignancy within 2 years of enrollment except for basal cell carcinoma
             of the skin, squamous cell skin cancer or carcinoma in situ of the cervix.

          -  Ability of subject to understand and the willingness to sign a written informed
             consent document

          -  Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage
             is permitted.

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation. Should a woman become pregnant or suspect she is
             pregnant while she or her partner is participating in this study, she should inform
             her treating physician immediately

          -  Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor,
             Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection
             of Solid Tumors .

        EXCLUSION CRITERIA:

          -  Patients who are receiving any investigational agents

          -  Disseminated extra-peritoneal or solid organ metastases

          -  Includes carcinomatosis associated with clinically or radiographically evident ascites
             (greater than 500cc)

             --Excludes greater omentum and ovarian metastases

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Pregnant women are excluded from this study because HIPEC and gastrectomy have not
             been studied in pregnant women and has the potential for teratogenic or abortifacient
             effects. Because there is an unknown but potential risk for adverse events in nursing
             infants secondary to treatment of the mother with HIPEC and gastrectomy, breastfeeding
             should be discontinued if the mother is treated on this study.

          -  HIV-positive patients may be considered for this study only after consultation with a
             NIAID physician.
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? Entailment