EUCTR2009-016782-28-DE进行中（未招募）不适用
Panitumimab in combination with radiotherapy in patients with locally advanced RAS wildtype rectal cancer (clinical stages II and III) - NEO-RIT
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH0 个研究点开始时间: 2010年6月11日最近更新:
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试验速览
研究概览
简要总结
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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
- •Locally advanced rectal cancer (stage II or III; EUS and MRI mandatory)
- •RAS wildtype mandatory (to be determined at accredited local
- •laboratory or pathology of Mannheim Univ.)
- •RAS wild-type tested in
- •? KRAS exon 2 (codons 12/13)
- •? KRAS exon 3 (codons 59/61)
- •? KRAS exon 4 (codons 117/146)
- •? NRAS exon 2 (codons 12/13)
- •? NRAS exon 3 (codons 59/61)
- •? NRAS exon 4 (codons 117/146)
- •PTEN expression result available (IHC - to be determined by pathology of
- •Mannheim Univ.)
- •adequate hematologic, hepatic, renal and metabolic parameters
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
排除标准
- •Distant metastases (excluded by CT scan)
- •cT4 tumor (excluded by MRI and EUS)
- •Risk of tumor involvement of the circumferential resection margin, according to the
- •MRI assessment
- •Sphincter sparing as the major reason for choosing the neoadjuvant treatment
- •Prior antineoplastic therapy for rectal cancer
研究者
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