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NCT01706432Completed

Hypofractionated Image Guided Radiation Therapy in Treating Patients With Stage IV Breast Cancer

Biologic Endpoints in the Annihilation of Metastases for Oligometastasis (BEAM ON)

Source: ClinicalTrials.gov · Last updated 31 Jul 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
4 (actual)
First submitted
5 Oct 2012
Start date
15 Jun 2009
Primary completion date
22 Jan 2024
Lead sponsor
University of Chicago
NCT number
NCT01706432

What you commit to

  • Study type: Observational
  • Participants enrolled: 4
  • From 15 Jun 2009 to the primary completion date, 22 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients are ineligible if they have had prior treatment for their metastatic disease within 3 years
  • Prior radiotherapy that would result in overlap of radiation therapy fields
  • Prior treatment with anti-angiogenic therapy
  • Evidence of pleural or pericardial effusion prior to study start; patients with pleural effusion that is transudative, cytologically negative, and non-bloody are eligible; if a pleural effusion is too small for diagnostic thoracentesis, the patient will be eligible

Other illness

  • Co-existing or prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Clinically significant pulmonary dysfunction, cardiomyopathy, any history of clinically significant congestive heart failure (CHF), unstable angina pectoris, or cardiac arrhythmia
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immunocompromised patients
  • Exudative, bloody or cytologically malignant effusions

Lab values

  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol

Other

  • Severe, active co-morbidity, defined as follows:
  • Pregnancy, breast feeding or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for at least three months following completion; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • Significant atelectasis such that CT definition of the gross tumor volume (GTV) is difficult to determine

Who the study is looking for

  • 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 \[Sa02\]) \> 90%
  • Life expectancy \> 3 months
  • Patient complete study specific informed consent process and sign consent form prior to study entry
  • Patients with prior metastatic treatment are eligible if they have been disease free for \> 3 years; participants may receive hormonal and Herceptin treatment at any time

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Chicago
Coordinator of this site? Confirm its status
North ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.