NL-OMON44466已完成2 期
Addition of stereotactic radiotherapy to the standard FOLFIRINOX treatment in locally advanced pancreatic cancer patients to determine efficacy and feasability (LAPC-1) - LAPC-1
Stichting Leveronderzoek0 个研究点目标入组 51 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Cytological or Histologically confirmed pancreatic cancer.
- •- WHO performance status of 0 or 1
- •- ASA classification I or II
- •- Tumor considered locally advanced after diagnostic work-up including CT-imaging
- •and diagnostic laparoscopy.
- •- No evidence of metastatic disease
- •- Largest tumor diameter < 7 cm x 7 cm x 7 cm
- •- Normal renal function (Creatinine * 30 ml/min).
- •- Normal liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal)
- •- Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and
- •hemoglobin > 5.6 mmol/l)
- •- Age > 18 years and < 75 years
- •- Written informed consent
排除标准
- •- Prior radiotherapy, chemotherapy or resection (bypass surgery allowed).
- •- Lymph node metastases from primary tumor outside the field of radiation.
- •- Second primary malignancy except in situ carcinoma of the cervix, adequately treated
- •non-melanoma skin cancer, or other malignancy treated at least 3 years previously
- •without evidence of recurrence.
- •- Pregnancy, breast feeding.
- •- Serious concomitant systemic disorders that would compromise the safety of the
- •patient or his/her ability to complete the study, at the discretion of the investigator.
研究者
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Unknown
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