EUCTR2012-005249-19-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 cetuximab with FOLFOX or FOLFIRI in RAS and B-RAF WT tumors.
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 RAS and B-RAF tumor status.
- •4. Patients must present a resectable metastatic disease at diagnosis with at least 3 metastases with one > 3cm. Resectability could be planed 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
- •HepaticBilirubin< or = 1.5 X ULN
- •AST, ALT < or = 5 x ULN
- •Phos Alc< or = 5 x ULN
- •9. Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
- •10. Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
- •11. 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 cetuximab, panitumumab (or other anti-EGFR 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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