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Prospective Evaluation of Low-dose Irinotecan and Cyberknife® Stereotactic Body Radiotherapy in the Treatment of Patients With Colorectal Cancer and Limited Liver Metastasis


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Prospective Evaluation of Low-dose Irinotecan and Cyberknife® Stereotactic Body Radiotherapy in the Treatment of Patients With Colorectal Cancer and Limited Liver Metastasis


Inclusion Criteria:



- Patient must be ≥ 18 years of age.

- Histologically proven primary colorectal carcinoma

- Patient is clinical stage IV (AJCC 7th Edition)

- Patient exhibits 1-4 liver metastasis

- Liver is only site of metastasis

- Chemotherapy administered prior to enrollment

- Life expectancy > 3 months

- At least 4 weeks from any chemotherapy

- CBC, platelets, LFTs, PTT all within normal institutional limits

- Patient's albumin level is >3gm/dl.

- Negative pregnancy test within 72 hours of study entry for women of childbearing
potential

- ECOG performance status 0-1

Exclusion Criteria:

- Prior radiotherapy to the liver

- Hepato renal syndrome

- Malignant ascites

- Chemotherapy for a malignancy in the last 5 years

- Inflammatory Bowel disease

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Arica Hirsch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Advocate Lutheran General Hospital

Authority:

United States: Institutional Review Board

Study ID:

5443

NCT ID:

NCT01847495

Start Date:

May 2013

Completion Date:

May 2023

Related Keywords:

  • Colorectal Cancer
  • Stage IV Colorectal Carcinoma
  • Liver metastasis
  • Cyberknife
  • Stereotactic Body Radiotherapy
  • SBRT
  • Irinotecan HCl
  • CPT-11
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

Name

Location

Advocate Lutheran General HospitalPark Ridge, Illinois  60068