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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

18 Years
Open (Enrolling)
Colorectal Cancer, Colorectal Carcinoma, Liver Metastases

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Trial Information

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

Inclusion Criteria:

- Unequivocal and measurable CT evidence of liver metastases which are not treatable by
surgical resection or local ablation.

- Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung:
5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one
single anatomic area (pelvis, abdomen or chest): any number, < 2 cm).

- Suitable for either treatment regimen.

- Prior chemotherapy for metastatic colorectal cancer is not allowed.

- WHO performance status 0-1.

- Adequate hematological, renal and hepatic function.

- Age 18 years or older.

- Willing and able to provide written informed consent.

- Life expectancy of at least 3 months without any active treatment.

Exclusion Criteria

- Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor
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 the protocol.

- Peripheral neuropathy > grade 1 (NCI-CTC).

- Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.

- Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for
colorectal cancer is not an exclusion criteria provided that it was completed more
than 6 months before entry into the study.

- Pregnant or breast-feeding.

- Other active malignancy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

from randomisation until progressive disease is confirmed or upon patient death if disease progression has not been evident at that time

Safety Issue:


Principal Investigator

Peter Gibbs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Melbourne Health


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

April 2018

Related Keywords:

  • Colorectal Cancer
  • Colorectal Carcinoma
  • Liver Metastases
  • colon cancer
  • Colorectal carcinoma
  • liver metastases
  • SIR-Spheres microspheres
  • yttrium-90
  • bevacizumab
  • metastatic colorectal cancer
  • Carcinoma
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms



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