Hypofractionated Image Guided Radiation Therapy in Treating Patients With Stage IV Breast Cancer (NCT01706432) | Clinical Trial Compass
CompletedNot Applicable
Hypofractionated Image Guided Radiation Therapy in Treating Patients With Stage IV Breast Cancer
United States4 participantsStarted 2009-06-15
Plain-language summary
This pilot clinical trial studies new ways to monitor the impact of hypofractionated image guided radiation therapy in treating patients with stage IV breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically proven diagnosis of breast cancer (invasive ductal, lobular, medullary, papillary, colloid, tubular)
* Completion of standard of care treatment for local and regional disease with no known residual
* American Joint Committee on Cancer (AJCC) (6th edition, 2002) Stage IV ( Any T, Any N, M1) based upon the following minimum diagnostic workup:
* History/physical examination within 8 weeks prior to registration
* Computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET) CT of the whole body within 60 days prior to registration
* MRI of the brain, if clinically indicated
* Documentation of 1-5 sites of metastatic tumor; each individual site of tumor must be =\< 10 cm or \< 500 cc volume and amenable to radiation therapy as seen on standard imaging (CT, MRI, bone scan)
* Pathology from at least one metastatic site confirming breast primary is recommended
* Zubrod performance status =\< 2 (Karnofsky \>= 60%)
* Absolute neutrophil count (ANC) \>= 1,800 cells/mm\^3
* Platelets \>= 100,000 cells/mm\^3
* Hemoglobin \>= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
* Total bilirubin within institutional limits
* Albumin \> 2.9 g/dl
* Alkaline phosphatase \< 2.5x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x ULN
* Room air saturation (saturated oxygen \[Sa02\])…
What they're measuring
1
Change in the number of circulating tumor cells
Timeframe: At baseline, 3-4 weeks post-treatment, and every 9-12 weeks for one year