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Central Nervous System MetastasesNCT01706432

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

An observational study of Central Nervous System Metastases and Invasive Ductal Breast Carcinoma, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
hyperfractionated radiation therapy, laboratory biomarker analysis and stereotactic radiosurgery
Type of treatment
Surgery or procedure
How many people
4 participants
Where
1 siteUnited States
Study dates
15 Jun 2009to 22 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients receiving radiation treatment for breast cancer.

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
  • 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)
  • Severe, active co-morbidity, defined as follows:
  • 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
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  • 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
  • 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
  • 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
  • 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
  • Prior treatment with anti-angiogenic therapy
  • Significant atelectasis such that CT definition of the gross tumor volume (GTV) is difficult to determine
  • Exudative, bloody or cytologically malignant effusions
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    North Chicago, Illinois, 60064

Other trials in United States

About this study

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

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.

Being tested
hyperfractionated radiation therapy, laboratory biomarker analysis, stereotactic radiosurgery
Medical subject headings
Carcinoma, Ductal, Breast, Carcinoma, Lobular, Breast Carcinoma In Situ, Breast Neoplasms, Male, Breast Neoplasms, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hyperfractionated radiation therapyRadiation

    Undergo hypofractionated radiation therapy

  • laboratory biomarker analysisOther

    Correlative studies

  • stereotactic radiosurgeryRadiation

    Undergo stereotactic radiosurgery

Study groups in NCT01706432
Study groupRoleWhat they receive
All participantsPatients will undergo standard of care radiation therapy and have research blood samples collected at following time points: * pre-treatment * 3-4 weeks post-treatment * every 9-12 weeks post-treatment for 1 year
Receives: Radiation: hyperfractionated radiation therapy; Other: laboratory biomarker analysis; Radiation: stereotactic radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the number of circulating tumor cells

    Measured: At baseline, 3-4 weeks post-treatment, and every 9-12 weeks for one year

Secondary outcomes (4)

  1. Progression free survival

    Measured: 5 years

  2. Overall survival

    Measured: 5 years

  3. Side effects of hypofractionated image guided radiotherapy

    Measured: During treatment (about 21 days)

  4. Number of patients with IRDS in tumor sample

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2012 (estimated)
  2. Study start15 Jun 2009
  3. Primary completion22 Jan 2024
  4. Study completion22 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706432
Sponsor's protocol ID
16802B
Other IDs
NCI-2011-03193
Status last verified
Jul 2024
First submitted
5 Oct 2012
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Central Nervous System Metastases and Invasive Ductal Breast Carcinoma, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the number of circulating tumor cells (time frame: At baseline, 3-4 weeks post-treatment, and every 9-12 weeks for one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01706432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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