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|Title||RFA ±ThermoDox for Colorectal Liver Metastases|
|Full Title||Randomized, Double-Blind, Phase II Trial of Radiofrequency Ablation + Lyso-Thermosensitive Liposomal Doxorubicin (ThermoDox®) for Colorectal Liver Metastases = 2 cm Maximum Diameter|
|Description||This is a study that will compare the helpfulness of using a medication called Thermdox during a procedure called Radiofrequency Ablation (RFA) that will treat colorectal cancer that has spread to the liver versus treatment with RFA alone. For comparison reasons, some patients will receive the procedure with the medication and some will receive the procedure with a sugar solution instead. Your doctor and you will not be aware of which treatment you received (Thermodox or Sugar Solution). After the procedure you will be followed for your progress for the course of three years according to the standard of care for persons with your type of cancer. Eligible colorectal cancer patients will have uncontrollable or returning disease with spread to the liver that cannot be treated by surgical removal. Subjects cannot have cancer spread to other vital organs. Subjects in the study will have 1-4 areas of the liver where the cancer has spread that are not bigger than 7 cm in size. Patients cannot have received the study medication before and cannot be on any other experimental treatment at the time of the study procedure. Patients must be willing to return to see study physician for CT scans every three months. |
Full Trial Details available at: http://clinicaltrials.gov/ct2/show/NCT01464593?term=colorectal+liver&rank=8
|Eligibility Criteria||1. Diagnosis of colorectal cancer, proven by biopsy or surgery.|
2. Uncontrolled or returning disease following an adequate trial of the chemotherapy regimen first used to treat the patient's colorectal cancer. An "adequate trial" means that the regimen was continued until completion of the planned number of cycles, objective disease progression was seen, or unacceptable toxicity developed.
3. No more than 4 places that the cancer has spread in the liver, which are not treatable with surgical removal, at baseline screening, with at least one = 2.0 cm and none > 7.0 cm in size; patients may also have other areas in liver where they are masses that are treated surgically.
o Confirm that lesions are cancer by a pretreatment biopsy.
o If a subject has a large lesion (5.0 - 7.0 cm), any other lesions must be less than 5.0 cm.
o If additional lesions are discovered during the RFA treatment procedure that were undetectable by CT at screening, the size and location of the lesion(s) will be treated at the discretion of the physician and guided by the local standard of care.
4. Be an appropriate candidate for RFA as a medically-indicated treatment as evaluated by the following factors:
o Number of lesions
o Size of lesions
o Overall health of liver\Exclusion Criteria:
5. Male or female 18 years of age or older.
6. Are willing to sign an informed consent form, indicating that they are aware of the investigational nature of this study that is in keeping with the policies of the institution.
7. Willing to return to the study site for study visits.
8. Have life expectancy of = 6 months.
|Exclusion Criteria||1. Surgery on colon at or around the same time of study treatment |
2. Have serious illnesses within the last 6 months.
3. Have previously received any doxorubicin
4. Have spread of your cancer outside of the liver.
5. Are pregnant or breast-feeding.
6. Have any known allergic reactions to any of the drugs or liposomal components or intravenous imaging agents to be used in this study.
7. Adequate Liver, kidney and cardiac functions
8. Are being treated with other investigational drugs.
9. Treatment with chemotherapy drugs within 30 days of treatment date for study
10. Have other types of cancer at the same time of treatment
11. Documented HIV positive
|Principal Investigator||Steven. K. Libutti, MD|
|Contact Name||Estella Forbes|
|Contact Email||Estella Forbes|
|Protocol Number||BRANY 11-06-111-01/ #104-10-201|