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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 570

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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