Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00463060
Eligibility Criteria:
Inclusion Criteria:
* Zubrod Performance Scale 0-1
* Metastatic disease confirmed by biopsy or imaging
* 5 or fewer sites of metastatic disease on tumor staging (either CT chest/abdomen/pelvis plus bone scan or whole body FDG-PET)
* All tumors measure \< 6 cm
* Age \> 18
* Chemotherapy must be completed at least 2 weeks prior to radiation
* Signed informed consent
* Adequate bone marrow function, defined as follows;
1. Platelets \> 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
2. Absolute neutrophil count (ANC) \> 1,800 cells/mm3 based on CBC/differential obtained within 2 weeks prior to registration on study
3. Hemoglobin \> 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb \> 8.0 g/dt is acceptable.)
Exclusion Criteria:
* Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical carcinoma in situ, and other treated malignancies with no evidence of disease for at least 3 years
* Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
* Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary heart disease will be at the discretion of the attending physician.
* Patients with exudative, bloody, or cytologically malignant effusions are not eligible.
* Pregnancy or breast feeding (Women of child-bearing potential are eligible, but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
* Patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
* Prior radiation to target area
* Patient may not be receiving any other investigational agents during radiotherapy.
* Prior history of non-inducible bleeding (12/16/09).
* Requirement for continuation of anticoagulation (defined as Coumadin, lovenox, heparin, plavix, aspirin, NSAIDs or similar drugs) during treatment (12/16/09)
* Under 18 years of age
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00463060
Study Brief:
Protocol Section:
NCT00463060