EUCTR2010-018327-26-NL进行中（未招募）1 期
Chemoradiation with gemcitabine in combination with panitumumab for patients with locally advanced pancreatic cancer.
VU University Medical Center0 个研究点开始时间: 2010年2月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histological or cytological confirmed pancreatic cancer.
- •2. Not eligible for curative resection.
- •3. No distant metastases present.
- •4. Previously untreated with chemotherapy and anti-cancer biologicals for current malignancy.
- •5. No other current malignant disease, except for basal cell carcinoma of the skin.
- •6. Measurable or evaluable disease as defined by RECIST 1.1 criteria.
- •7. Performance status 0–2 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scale.
- •8. Age = 18 years.
- •9. Adequate haematological and biological functions:
- •Bone marrow function:
- •a. Neutrophils = 1.5 x 109/L
- •b. Platelets = 100 x 109/L
- •c. Hb = 6 mmol/L
- •Hepatic function:
- •a. AST/ALT and alkaline phosphatase (ALP) = 2.5 x institutional upper limit of normal (ULN)
- •b. Bilirubin = 1.5 times institutional ULN
- •Renal function:
- •eGFR >50ml/min
- •Metabolic Function:
- •a. Magnesium = lower limit of normal
- •b. Calcium = lower limit of normal.
- •10. No imminent bowel obstruction.
- •11. No active bleeding.
- •12. No uncontrolled infection.
- •13. Patients with reproductive potential must use effective contraception. Female patients must have a negative pregnancy test.
- •14. Signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participation in another therapeutic clinical study within 30 days of enrollment or during this clinical study.
- •2. No adequate radiation therapy possible: based on the opinion of the radiation oncologist when radiation therapy cannot be performed because radiation field is too large (PTV volume too large or OAR too high)
- •3. History of allergic reactions to gemcitabine or antibody treatment.
- •4. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection, uncontrolled hypertension).
- •5. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 1 year before enrolment/randomization
- •6. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance.
- •8. Pregnant or breastfeeding women.
- •9. Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment.
- •10. Known positive status for HIV and/or hepatitis B or C.
- •11. Any reason why, in the investigator’s opinion, the patient should not participate in the study.
- •12. Drug or alcohol abuse.
研究者
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