KCT0006378
Withdrawn
未知
MR guided Pre-operative RT in Gastric Cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Washington University School of Medicine
- Enrollment
- 18
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.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 and T3Nx disease are eligible (stage I\-III). Patients with T2N0, N3, T4, M1, or T1N0 disease are not eligible.
- •2\.T\-stage defined by EUS. Must have had CT of the chest/abdomen/pelvis with oral and IV contrast.
- •3\.Medically eligible to receive CAPOX chemotherapy.
- •4\.At least 18 years of age (per US calculation of age).
- •5\.ECOG performance status \= 2 (see Appendix A)
- •6\.Normal bone marrow and organ function as defined below:
- •a.Absolute neutrophil count \= 1,500 cells/mm3
- •b.Platelets \= 100,000 cells/mm3
- •c.Hemoglobin \> 9 g/dL
- •d.Creatinine clearance \> 50 mL/min
Exclusion Criteria
- •1\.Prior surgery, radiation, or chemotherapy for gastric or esophageal cancer.
- •2\.Prior surgery to the esophagus or stomach.
- •3\.Siewert I\-II GE junction tumor.
- •4\.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).
- •5\.Currently receiving any other investigational agents.
- •6\.Metastatic disease, including gross peritoneal carcinoma.
- •7\.Presence of ascites.
- •8\.A history of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine, oxaliplatin, or other agents used in the study.
- •9\.Contraindications to MRI (e.g., non\-compatible implantable device or metallic foreign bodies).
- •10\.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Outcomes
Primary Outcomes
Not specified
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