jRCT1040230005招募中不适用
Development precision prognostic model through genotype-based optimization of tumor marker cut-offs under induction systemic therapy for pancreatic cancer 01/02 (GEMINI-PC-01/02)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20age old over 至 79age old under（—）
- 性别
- All
入选标准
- •(1) Patients diagnosed with pancreatic cancer by various diagnostic imaging methods between January 1, 2010 and December 31, 2025 and who will receive induction chemotherapy (radiation therapy) (histological evidence is not required).
- •(2) Life expectancy is judged to be at least 6 months by the investigator(s).
- •(iii) Age at enrollment is between 20 and 79 years old.
- •Performance Status (ECOG) is 0 or
- •(5) Patients must be undergoing initial treatment for pancreatic cancer (patients may be undergoing a series of treatments at the time of enrollment).
- •(6) No prior chemotherapy treatment within 3 years
- •(7) No concurrent cancer of other organs
- •(8) Able to take oral intake
- •(ix) If the patient has obstructive jaundice, appropriate drainage has been performed.
- •(10) Main organs are fully functional (within 14 days prior to enrollment).
- •White blood cell count: greater than 3,000/mm3 and less than 12,000/mm3
- •Neutrophil count: 1,000/mm3 or higher
- •Hemoglobin level: 8.0 g/dl or more
- •Platelet count: 75,000/mm3 or higher
- •Total bilirubin: 3.0 mg/dL or less*.
- •Patients undergoing antiasthmatic surgery for obstructive jaundice should be treated under 3.5 mg/dL.
- •AST and ALT levels: 150 U/L or less
- •Creatinine: 2.0 mg/dl or less
- •Creatinine clearance: 20 mL/min or more
- •(Estimation by the Cockcroft-Gault formula* is acceptable, but if actual measurements are available, the actual measurements will be used as the eligibility criteria.)
- •Cockcroft-Gault formula
- •Male CCr = weight x (140 - age)/(72 x creatinine)
- •Female CCr = weight x (140 - age)/(72 x creatinine) x 0.85
- •(11) Consent for participation in this study has been obtained from the individual (However, if it is difficult to obtain informed consent because the individual is no longer attending the hospital or has died, please contact the Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, and the Department of Medicine, Faculty of Academic Research, University of Toyama, Department of Gastroenterology, University of Toyama. and Oncology and General Surgery, Nagoya Medical Center, and the Nagoya Medical Center Clinical Research Center will guarantee the opportunity to refuse by disclosing information on their websites.)
排除标准
- •1 Patient's life expectancy is judged to be less than 6 months by the investigator(s)
- •2 History of serious drug hypersensitivity or drug allergy
- •3 Patients with obvious infection or inflammation (e.g., fever over 38.0)
- •4 Serious (requiring hospitalization) cardiac disease or history of cardiac disease
- •5 Have a serious (requiring hospitalization) underlying disease (intestinal paralysis, intestinal obstruction, diabetes mellitus that is difficult to control, renal failure, cirrhosis of the liver, etc.)
- •6 Have active multiple cancers (simultaneous multiple cancers and iatrogenic multiple cancers with a disease-free period of less than 5 years. However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered cured by local treatment are not included in active overlapping cancers).
- •7 Ascites or pleural effusion that is difficult to control
- •8 Fresh gastrointestinal bleeding requiring repeated blood transfusions
- •9 Diarrhea (more than 4 times a day or watery stools)
- •10 Peripheral sensory neuropathy or peripheral motor neuropathy with CTCAE Grade 3 or higher
- •11 Pulmonary fibrosis or interstitial pneumonia that is evident on chest radiographs or is clinically symptomatic
- •12 Psychosis or psychiatric symptoms that would preclude participation in the study
- •13 Pregnant or lactating women and women of childbearing potential (intention)
- •14 Patients who did not give consent to participate in this study
- •15 Other patients who are judged by the investigator(s) to be unsuitable for the study.
结局指标
主要结局
-
OOS
次要结局
未报告次要终点
研究者
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