RANDOMISED COMPARATIVE STUDY OF FOLFOX6m PLUS SIR-SPHERES MICROSPHERES VERSUS FOLFOX6m ALONE AS FIRST LINE TREATMENT IN PATIENTS WITH NONRESECTABLE LIVER METASTASES FROM PRIMARY COLORECTAL CARCINOMA - SIRFLOX study

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 318

Inclusion Criteria

Willing and able to provide written informed consent.
- Histologically confirmed adenocarcinoma of the colon or rectum OR radiological evidence of carcinoma of the colon or rectum. - 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 abdominal lymph nodes are permitted. Metastases in the lung must be not more than five nodules in number with no nodule more than 1 cm in diameter. Involvement of abdominal lymph nodes are permitted provided they measure less than 2 cm in diameter. - Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator. - Prior chemotherapy for metastatic colorectal cancer is not allowed. Patients may have received both adjuvant chemotherapy and/or radiotherapy following resection of the primary colorectal cancer, provided the last dose of chemotherapy and/or radiotherapy was administered at least 6 months prior to entry into this study. - WHO performance status 0 - 1 - Adequate haematological, renal and hepatic function - 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment. - Any extra-hepatic metastases other than (a) lung metastases that are not more than five nodules in number with no nodule more than 1 cm in diameter and (b) involvement of abdominal lymph nodes that measure less than 2 cm in diameter. - Previous radiotherapy delivered to the upper abdomen. - Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. - Equivocal, immeasurable, or unevaluable metastases in the liver. - 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. - Other active malignancy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary outcome of this study is improvement of the progression free survival.;Secondary Objective: Progression free survival in the liver; Overall survival; Tumour response rate (liver ? any site); Hepatic and extra-hepatic recurrence rate; Quality of life; Toxicity and Safety; Liver resection rate;;Primary end point(s): The primary outcome of this study is progression free survival. Progression-free survival (PFS) is defined as the time interval between randomisation and the date of tumour progression.

Secondary Outcome Measures

Name	Time	Method

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