EUCTR2008-003737-25-DE进行中（未招募）1 期
Randomised comparative study of folfox6m plus SIR-Spheres microspheres versus folfox6m alone as first line treatment in patients with non-resectable liver metastases from primary colorectal carcinoma - SIRFLOX
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
- 570
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
- •- Willing and able to provide written informed consent.
- •- Histologically confirmed adenocarcinoma of the colon or rectum,with or without primary tumour in situ
- •- Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of trial entry
- •- Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no nodule more than 1 cm in diameter or 1 lesion of up to 1.7cm in diameter. Involvement of lymph nodes in 1 anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm.
- •- Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator.
- •- All imaging evidence used as part of the screening process must be within 28 days prior to the time of randomisation
- •- Prior chemotherapy for metastatic colorectal cancer is not allowed. 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 entry into this study. Radiotherapy to the pelvis is not an exclusion criterion
- •- WHO performance status 0 - 1
- •- Adequate haematological, renal and hepatic function as follows:
- •Haematological: Neutrophils >1.5 x 10^9/L
- •Platelets >100 x 10^9/L
- •Renal: Creatinine <1.5 x ULN
- •Hepatic: Billirubin <=30 µmol/L
- •Albumin >=30 g/L
- •The date of blood tests must be within 28 days prior to the time of randomisation
- •- Aged 18 years or older.
- •- Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
- •- Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
- •- 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 443
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 127
- •- Willing and able to provide written informed consent.
- •- Histologically confirmed adenocarcinoma of the colon or rectum,with or without primary tumour in situ
- •- Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of trial entry
- •- Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no nodule more than 1 cm in diameter or 1 lesion of up to 1.7cm in diameter. Involvement of lymph nodes in 1 anatomic region (pelvis, abdomen or chest) are permitted provided their longest diameter measures less than 2 cm.
- •- Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator.
- •- All imaging evidence used as part of the screening process must be within 28 days prior to the time of randomisation
- •- Prior chemotherapy for metastatic colorectal cancer is not allowed. 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 entry into this study. Radiotherapy to the pelvis is not an exclusion criterion
- •- WHO performance status 0 - 1
- •- Adequate haematological, renal and hepatic function as follows:
- •Haematological: Neutrophils >1.5 x 10^9/L
- •Platelets >100 x 10^9/L
- •Renal: Creatinine <1.5 x ULN
- •Hepatic: Billirubin <=30 µmol/L
- •Albumin >=30 g/L
- •The date of blood tests must be within 28 days prior to the time of randomisation
- •- Aged 18 years or older.
- •- Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception.
- •- Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception.
- •- 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 443
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 127
- 另有 25 项未显示
排除标准
- •- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.
- •- Previous radiotherapy delivered to the upper abdomen.
- •- Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
- •- Peripheral neuropathy > grade 1 (NCI-CTCv3).
- •- Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy.
- •- Previous chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before the documentation of metastatic disease.
- •- Pregnant or breast feeding.
- •- Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix.
- •- Allergy to non-ionic contrast agents
- •- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.
- •- Previous radiotherapy delivered to the upper abdomen.
- •- Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
- •- Peripheral neuropathy > grade 1 (NCI-CTCv3).
- •- Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy.
- •- Previous chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before the documentation of metastatic disease.
- •- Pregnant or breast feeding.
- •- Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix.
- •- Allergy to non-ionic contrast agents
- •- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment.
- •- Previous radiotherapy delivered to the upper abdomen.
- •- Non-malignant disease that would render the patient unsuitable for treatment according to this protocol.
- •- Peripheral neuropathy > grade 1 (NCI-CTCv3).
- •- Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy.
- •- Previous chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before the documentation of metastatic disease.
- •- Pregnant or breast feeding.
- •- Concurrent or prior history of cancer other than adequately treated non melanoma skin cancer or carcinoma in situ of the cervix.
- •- Allergy to non-ionic contrast agents
研究者
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