Status:

WITHDRAWN

Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis

Lead Sponsor:

Wake Forest University Health Sciences

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to determine the effects of CyberKnife stereotactic body radiotherapy in combination with irinotecan chemotherapy in patients with colon or rectal cancer that has spread t...

Eligibility Criteria

Inclusion

  • Age\>18 years
  • Histologically confirmed primary colorectal cancer
  • Stage IV colorectal cancer with \</= 3 metastases, up to 5cm in size.
  • CT scan or MRI of the abdomen with contrast, 60days prior to enrollment
  • If patient is allergic to contrast, imaging without contrast is acceptable
  • Positron-Emission Tomography 60 days prior to enrollment
  • No additional sites of metastasis at the time of protocol enrollment. History of other sites of metastasis that are currently controlled are acceptable.
  • No malignant ascites
  • At least 4 weeks from any chemotherapy
  • No prior liver radiation therapy
  • ECOG performance status 0-1
  • Life expectancy\>3months
  • Laboratory evaluations completed 60 days prior to treatment including CMP, CBC with differential, liver function test, and prothrombin time.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 29 2017

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT01847495

    Start Date

    October 1 2013

    End Date

    November 29 2017

    Last Update

    October 4 2024

    Active Locations (1)

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    Advocate Lutheran General Hospital

    Park Ridge, Illinois, United States, 60068