SIRFLOX Study

Not Applicable

Recruiting

• Conditions: iver metastases from colorectal cancer; Liver metastases from colorectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Liver

• Registration Number: ACTRN12606000153516
• Lead Sponsor: Sirtex Technology Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

Histologically confirmed adenocarcinoma of the colon or rectum OR radiological evidence of carcinoma of the colon or rectum together with elevated serum CEAUnequivocal contrast CT OR histologic/cytologic evidence of malignant metastases in the liverLimited extra-hepatic metastases in the lung and/or abdominal lymph nodes are permitted. Metastases in the lung must not be more than 5 nodules in number with no nodule more than 2 cm in diameter. Involvement of abdominal lymph nodes are permitted provided they measure less than 5 cm in diameter.All imaging evidence used as a basis for study entry must be less than 29 days old at the time of study entry.Liver metastases are not treatable by surgical resection or by some form of local ablation with the intent of curing the patient.Suitable for either treatment regimen as determined by clinical assessment undertaken by the investigator.Prior chemotherapy for metastatic colorectal cancer is not allowed.Adequate haematological, renal and hepatic function. Willing and able to provide written informed consentFemale patients must either be post menopausal, sterile or if sexually active using an acceptable method of contraception.Life expectancy of at least 3 months without any active treatment.

Exclusion Criteria

Evidence of ascites, cirrhosis or portal hypertension as determined by clinical or radiologic assessment.Previous radiotherapy delivered to the upper abdomenNon-malignant disease that would render the patient unsuitable for treatment according to protocolEquivocal, immeasurable, or unevaluable metastases in the liverPeripheral neuropathy > grade 1 (NCI-CTC)DLT associated with previous adjuvant 5-FU or oxaliplatin chemotherapyPrevious chemotherapy for any malignancy. Adjuvant chemotherapy completed more than 4 months before the documentation of metastatic disease.Pregnant or breast-feeding womenOther active malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival at any site[Progression to be assessed by CT scan every 2 months.]

Secondary Outcome Measures

Name	Time	Method
Overall survival[Time from randomisation until death of participant];Tumour response rate[Assessed based on CT scan evidence every second month until progression.];Hepatic and extra-hepatic recurrence rate[Assessed by CT scan every second month until progression of disease.];Quality of Life[Assessed at 3 monthly intervals until progression then 6 monthly.];Liver resection rate[Proportion of patients that undergo liver resection prior to progression of disease.];Progression free survival in the liver[Assessed by time from randomisation to time of progression in the liver, as assessed by CT scan]