Clinical trial: MR-guided Pre-operative RT in Gastric Cancer (NCT04162665)

Eligibility criteria:
Inclusion Criteria:

          -  Newly diagnosed histologically or cytologically gastric adenocarcinoma. (Siewert III
             acceptable: the bulk of tumor should be in stomach; gastric tumors with extension to
             the gastroesophageal junction are permitted.) Patients with T1-T2N1-2 and T3N0-2
             disease are eligible (stage I-III). Patients with T1-2N0, N3, T4, or M1 disease are
             not eligible.

          -  T-stage defined by EUS. Must have had CT of the chest/abdomen/pelvis with contrast.

          -  Medically eligible to receive CAPOX chemotherapy

          -  At least 19 years of age

          -  ECOG performance status ≤ 2

        Normal bone marrow and organ function as defined below:

          -  Absolute neutrophil count ≥ 1,500 cells/mm3

          -  Platelets ≥ 100,000 cells/mm3

          -  Hemoglobin > 9 g/dL

          -  Creatinine clearance > 50 mL/min

               -  The effects of the various chemotherapy agents used in this study on the
                  developing human fetus are unknown. For this reason, women of childbearing
                  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 participating in this study, she must inform her treating physician
                  immediately. Men treated or enrolled on this protocol must also agree to use
                  adequate contraception prior to the study, for the duration of the study, and one
                  month after completion of the study

               -  Ability to understand and willingness to sign an IRB approved written informed
                  consent document (or that of legally authorized representative, if applicable).

        Exclusion Criteria:

          -  Prior surgery, radiation, or chemotherapy for gastric or esophageal cancer.

          -  Prior surgery to the esophagus or stomach.

          -  Siewert I-II GE junction tumor

          -  Any active malignancy within 2 years that may alter the course of gastric cancer.
             (Apparently cured localized malignancy or advanced, but indolent malignancy with
             significantly more favorable prognosis are allowed).

          -  Currently receiving any other investigational agents.

          -  Metastatic disease, including gross peritoneal carcinoma

          -  Presence of ascites

          -  A history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to capecitabine, oxaliplatin, or other agents used in the study.

          -  Contraindications to MRI (e.g., non-compatible implantable device or metallic foreign
             bodies).

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris,
             or cardiac arrhythmia.

          -  Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
             pregnancy test within 14 days of study entry.

          -  Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or
             they have a history of AIDS-defining opportunistic infection within the 12 months
             prior to registration. Concurrent treatment with effective ART according to DHHS
             treatment guidelines is recommended. Recommend exclusion of specific ART agents based
             on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent
             strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be
             contraindicated).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 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