CyberKnife® for Hepatic Metastases From Colorectal Cancer

Launched by ACCURAY INCORPORATED · Mar 17, 2011

Keywords

ClinConnect Summary

Colorectal cancer is the fourth most commonly diagnosed malignant disease worldwide, with an estimated 1,023,000 new cases and 529,000 deaths each year. The liver is the most frequent site of metastatic spread from colorectal cancer, 25% of colorectal cancer patients will have liver metastases at the time of initial colorectal resection and more than 50% of colorectal cancer patients will develop liver metastases during the course of the disease.

The current standard of care and only potential curative therapy for colorectal liver metastases is liver resection of the metastatic lesions. Su...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Male or Female
• • Hepatic metastases from histologically confirmed colorectal adenocarcinoma
• • 3 hepatic lesions or less present
• • Cumulative size of hepatic lesions between 1 and 10 cm
• • Treatment determined by the liver/GI tumor board or equivalent organization at the participating site
• • Metastatic disease not amenable to surgery as assessed by the panel (including a surgeon) or patient who refuses surgery
• • Patient must be able to undergo contrast enhanced CT for planning
• • Age \>= 18 years old
• • Performance Status (ECOG) ≤ 2
• • Minimum of 6 months between the initial diagnosis of the disease and the first hepatic metastasis
• • Minimum of 4 weeks between prior chemotherapy or targeted therapy and the first CyberKnife session
• • Total bilirubin ≤ 3 times the upper limit of normal, ASAT and ALAT ≤ 5 times the upper limit of normal
• • Albumin \>= 36 g/L and lymphocytes \>= 700/mm3
• • No contraindication to fiducials implantation, hemostasis problems shall be corrected before implantation
• • Life expectancy \>= 3 months
• • Patient affiliated with a health insurance system. Applicable for French patients only.
• • Patient having signed the informed consent
• Exclusion Criteria:
• • Prior abdominal radiation therapy
• • Any evidence of visible intra-hepatic bile duct dilatation on pre-treatment images
• • Extrahepatic metastases
• • Current evidence of ascitis
• • Renal insufficiency (creatinine clearance \< 45 ml/min)
• • Known allergy to gold
• • Pregnant or lactating woman
• • Prior history of other cancer except basocellular carcinoma and in situ cervix carcinoma
• • Patient already enrolled in another therapeutic clinical trial
• • Inability to comply with follow-up visits for geographical, social or psychological reasons