EUCTR2012-005376-34-BE进行中（未招募）1 期
Randomized Phase 2 study comparing pathological responses observed on colorectal cancer metastases resected after preoperative treatment combining bevacizumab with FOLFOX or FOLFIRI. - BEV-ONCO2012
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
- 60
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. Female or male patients with at least 18 years at the time the informed consent is signed
- •2. EGOG performance status 0 or 1
- •3. Histological or cytological confirmed diagnostic of adenocarcinoma of the colon or rectum, with or without primary tumour in situ. Wild-type or mutated KRAS tumor status.
- •4. Patients must present a resectable metastatic disease for which the decision of preoperative chemotherapy is considered. Resectability could be planned in one or multiple stage if indicated. As commonly admitted, resectability means the surgical clearance (+/- radiofrequency ablation) of all detectable (liver) lesions with tumor-free margins and compatible with an adequate hepatic reserve.
- •5. Partial and minor resection of metastatic disease is allowed within 3 months before inclusion if patient has never received chemotherapy for mCRC.
- •6. Extra hepatic metastatic location is limited to 1 site. Extra-hepatic location must be easily resectable in one stage surgery.
- •7. Patients may have received adjuvant chemotherapy or (neo-) adjuvant chemo-radiotherapy to the pelvis, provided the last dose of chemotherapy was administered at least 6 months prior to inclusion (12 months for oxaliplatin). Previous radiotherapy to the pelvis is not an exclusion criterion.
- •8. Adequate haematological, renal and hepatic function as follows:
- •HaematologicalNeutrophils > 1.5 x 109/L
- •Platelets> 100 x 109/L
- •Renal Creatinine< 1.5 x ULN
- •HepaticBilirubinAST, ALT Phos Alc9. Proteinuria <2+ (dipstick urinalysis) or =1g/24hour.
- •10. No history of myocardial infarction and/or stroke within 6 months prior to randomization. No uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy.
- •11. Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
- •12. Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
- •13. Life expectancy of at least 3 months without any active treatment.
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Non resectable mCRC at diagnosis.
- •2. Prior chemotherapy or systemic therapy for mCRC. Adjuvant chemotherapy for colorectal cancer is not an exclusion criterion provided that it was completed more than 6 months prior to inclusion. Oxaliplatin-based chemotherapy must be completed more than 1 year prior to inclusion.
- •3. Prior utilization of bevacizumab, aflibercept (or other anti-VEGF therapy).
- •4. Previous radiotherapy delivered to the upper abdomen.
- •5. Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.
- •6. Prior major liver resection: remnant liver < 50% of the initial liver volume.
- •7. Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
- •8. Concurrent central nervous systems metastases
- •9. Peripheric neuropathy = grade 2.
- •10. Interstitial lung disease
- •11. Pregnant or breast feeding.
- •12. The patient has previous or concomitant malignancies, except: Invasive malignancies in remission for more than 5 years and non melanoma skin cancer or carcinoma in situ of the cervix.
研究者
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