EUCTR2009-011325-14-BE进行中（未招募）1 期
Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients with Locally Advanced Rectal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
- •Minimum age of 18 years old.
- •Performance status : ECOG 0 to 1.
- •Histologically proven rectal adenocarcinoma.
- •Wild-type K-Ras.
- •T3-T4 or/and nodal involvement visualized by rectal ultrasound and/or MRI.
- •No metastasis.
- •No prior pelvic irradiation.
- •Normal bone marrow, hepatic and renal function.
- •Absence of active second malignancy during the last 5 years.
- •Signed informed consent.
- •Presence of effective contraception in fertile patients.
- •Absence of any other uncontrolled severe pathology precluding administration of chemotherapy and radiotherapy.
- •No other conditions (psychological, familial, sociological, geographical) which could interfere with the compliance to the study protocol and follow-up.
- •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
- •Metastasis (established or suspected).
- •K-Ras mutation.
- •Previous exposure to EGF and/or EGFR-targeting therapies.
- •Concurrent immune therapy, chemotherapy, hormone therapy, or any other investigational agents within 4 weeks prior to enrollment.
- •Prior pelvic irradiation.
- •Grade 3-4 allergic reaction to any components of the treatment.
- •Severe and uncontrolled cardiovascular disease.
- •History of interstitial lung disease confirmed by radiology.
- •Drug and/or alcohol abuse.
- •Absence of reliable informed consent.
研究者
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